Symptoms and General Pathology

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Syndrome

Polycystic Ovary Syndrome

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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Reproductive Control Agents

Androgens

Chorionic Gonadotropin

1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
3. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

R. Jeffrey Chang, M.D.

Women with PCOS suffer from excess male hormone (androgen) production by the ovary. Androgen is made by cells that surround follicles that contain eggs. As the follicles (and eggs) grow and mature, there are more androgen producing cells. Women with PCOS have more follicles than normal women and therefore more androgen producing cells. While androgen production has been associated with the number of follicles, the relationship to the individual size of follicles in PCOS or normal women. This study intends to determine whether the size and number of ovarian follicles are correlated to androgen production in PCOS and normal women.

In women with polycystic ovary syndrome (PCOS), the major abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to LH stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgen. Stimulatory agents have included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU.

The investigators recently showed that hCG administered intravenously in a dose-response fashion revealed gradual increases of 17P and a non-dose dependent increase of serum T and A. The pattern of steroid hormone production revealed the predominant pathway by which androgens are generated in women with PCOS. Extending these studies, the investigators selected the mid-maximal dose of hCG to stimulate ovarian androgens and included morphometric measures of the ovary, such as ovarian follicle number (as determined by ultrasound) and related hormones, such as anti-mullerian hormone and inhibin B, both products of the ovarian follicle. The results showed that increased androgen and 17P responses in PCOS women were associated with increased antral follicle number and greater AMH levels compared to normal women. Inhibin B levels were similar between groups.

Based on responses observed in normal women, the PCOS women were divided into two groups. Those with 17P responses that did not exceed the normal mean plus 2 standard deviations (normal responder PCOS; NR-PCOS) and those that did exceed the normal response (high responder PCOS; HR-PCOS). This separation occurred at a rate of 50%. Notably, serum AMH levels were 2-fold higher in NR-PCOS compared to HR-PCOS. This finding was puzzling as serum AMH levels have been shown to correlate to the number of small follicles present in ovaries suggesting that AMH may be a surrogate for small follicle number. However, both PCOS subgroups had equivalent follicle numbers. The investigators hypothesize that the NR-PCOS have greater number of small follicles compared to HR-PCOS. To address this issue the investigators propose to assess the number of small follicles in NR- and HR-PCOS women and normal controls.

In a secondary consideration the HR-PCOS group was heavier than the NR-PCOS. This implies that the HR-PCOS women may have had greater insulin resistance and hyperinsulinemia that may have contributed to the significantly higher 17P responses to hCG. As a result, the investigators will also perform an oral glucose tolerance test in all subjects.

Power Analysis Results of the investigators' pilot study have shown that approximately 50% of PCOS women will exhibit 17OHP responses to hCG stimulation similar to those of normal women. Consequently, a sample size of 20 subjects in each group has an 80% power to detect a difference in the means of 0.820 ng/ml (the difference between the average 17OHP expression level in high responder PCOS women (HR-PCOS), 2.840 ng/ml, and that of normal responder PCOS (NR-PCOS) women, 2.02 ng/ml), which is a 33% increase. In the proposed study, the investigators believe that HR-PCOS (n=20) will show significantly greater (33% more) 17OHP production in response to hCG stimulation than NR-PCOS (n=20) at a power of 0.8 and a type I error rate of 0.05. The investigators will recruit 25 subjects in each group to allow for subject drop out. A secondary analysis will be performed between women with PCOS and normal controls (n=20).

Ovarian Morphology and Theca Cell Androgen Production in Women With Polycystic Ovary Syndrome (PCOS)

On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

Blood samples will be obtained before and after r-hCG adminstration

University of California, San Diego

Professor, Reproductive Endocrinology. Fellowship Director

There were no untoward or unfavorable medical occurrences in participating subjects.

1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
3. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

Normal Adult Women

Women With PCOS

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Sex and gender

R. Jeffrey Chang

Normal adult women and adult women with PCOS

Percent Change of 17-OHP Levels From Baseline

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

Tamoxifen

Patients at high risk for breast cancer will be treated with hCG

Patients receiving routine care will be followed

recombinant hCG subcutaneous injections x 30 doses every other day lasting 60 days total.

Giuseppe Del Priore, MD, MPH

Alan S Klapper, MD

Steven Freidman, MD

Joseph Bottino, MD

Raffi Chalian, MD

The purpose of the study is to evaluate whether hCG will result in a decrease in breast density.

High breast density has been associated with an increased risk in breast cancer. It has also been shown that decreasing density with a drug called tamoxifen has resulted in a decreased risk in breast cancer. The investigators are looking at the effect of hCG on breast density in people who are at increased risk of developing breast cancer and our theory postulates that through the hormonal actions of hCG and tamoxifen there would be a greater reduction in breast density in patients who are treated with hCG and tamoxifen versus patients treated with tamoxifen alone. Using this data the investigators will be able to hypothesize that the treatment of hCG will result in a reduction in breast cancer rates in the population and thus make available another drug which can be used to decrease the rates of breast cancer in the population

Pregnancy has been associated with a decreased risk of breast cancer. This has been reproduced in multiple studies and has been seen in multiple races.

People have been evaluating different hormones and practices associated with pregnancy to determine what factors reduce the risk of developing breast cancer in these patients. These pronounced findings have been evaluated in great detail by multiple scientists and one of the hormones which we think might be associated with a reduction in breast cancer is hCG. This statement has been backed by multiple studies which have looked at the direct effect of hCG on the growth and death of breast cancer cells in the lab and in animal models of breast cancer.

We want to determine if hCG is given to patients who are at increased risk of breast cancer will result in an accentuated decrease in breast cancer risk above and beyond the effect received by conventional breast cancer reducing protocols. Our final outcome in this study will be breast density on mammographic evaluation which is considered a marker for breast cancer. So our study will evaluate whether or not hCG will have an effect on the mammographic breast density.

After recruitment there will be two groups in our study an intervention group and non intervention group. In the intervention group patients would undergo a period of hCG injections which would last a total of 60 days and consist of 30 subcutaneous injections. The non intervention group will continue their conventional chemoprevention medication. Both groups will be followed for teo years and the images, cytology and blood samples will be sent to our labs for evaluation.

Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women

Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women.

New York Presbyterian Hospital

Giuseppe Del Priore

Hormones

Triptorelin Pamoate

Hormone Antagonists

No hormonal injection before oocytes retrieval

No hormone

a subcutaneous injection of hCG (Choriogonadotropin alpha, Ovitrelle®, Merck Serono, 250 µg) is performed 36 hours before oocytes retrieval

a subcutaneous injection of GnRH agonist (triptorelin, Decapeptyl, Ipsen, 0,2 mg) is performed 36 hours before oocytes retrieval

GnRH a

Charlotte Sonigo, MD, PhD

Michael Grynberg, Prof

Michael Grynberg, Professor

Oocyte vitrification after in vitro maturation (IVM) is one of the main techniques for preserving female fertility before chemotherapy for breast cancer. In this technique, originally developed for patients with ovarian pathology, polycystic ovarian syndrome, induction of an LH peak has been shown to improve outcomes. Young women with breast cancer, who are candidates for urgent fertility preservation, do not have ovarian pathology. The objective of the present study is to assess whether the absence of therapeutic intervention prior to oocyte retrieval for IVM in these patients is at least as effective as the injection of hCG or GnRH agonist used in routine practice.

In vitro maturation (IVM) is an assisted reproductive technology which consists in the retrieval of immature cumulus-oocyte complexes (COCs) from small antral follicles, followed by their in vitro maturation in specific culture conditions. Oocytes having reached metaphase II (MII) stage after 24 to 48 hours of IVM can then be fertilized. This procedure was first developed for patients presenting polycystic ovarian syndrome (PCOS), in order to avoid ovarian hyperstimulation syndrome (OHSS), an iatrogenic consequence of exogenous gonadotropins administration. However, the increasing use of GnRH antagonist protocols allowing ovulation trigger with GnRH agonist has dramatically reduced the indication of IVM in women at risk of OHSS. Yet, evidence indicate that IVM may be considered for patients presenting FSH resistance or contraindications to controlled ovarian stimulation. The recent development of female fertility preservation (FP) renewed interest to this technique. Indeed, it can be performed without any prior ovarian stimulation and whatever the phase of the menstrual cycle. Although it is still considered experimental, oocyte vitrification following IVM has been applied in different groups of patients, in particular those diagnosed with breast cancer, autoimmune or ovarian diseases. In physiologic conditions, final follicular maturation is induced by a double FSH and LH release which occurs when the dominant follicle reaches approximately 17 to 20 mm in diameter. This gonadotropin surge usually precedes the follicular rupture and mature oocyte release from 36 to 40 hours. In case of an assisted reproductive treatment, two strategies can be used to reproduce this hormonal signal: (i) either an injection of hCG, which binds to the LH receptor on granulosa cells, (ii) or a GnRH agonist (GnRHa) administration which induces an endogenous double peak of LH and FSH through a "flare up effect". Miming common practice for in vitro fertilization, priming with hCG or GnRHa injection 36 hours before the COCs retrieval has been suggested for patients undergoing IVM procedure in order to improve oocyte maturation rates and further IVM outcomes. Indeed, it is hypothesized that these iatrogenic hormonal activities might enhance the final oocyte maturation in vivo, therefore shortening the duration of the overall IVM process. Actually, in PCOS patients, several line of evidence indicate that IVM outcomes are improved after hCG priming. This positive effect might be explained by a premature expression of LH receptors on granulosa cells of small antral follicles \<10 mm in diameter. Nevertheless, in normo-ovulatory non PCOS patients, LH receptor expression in these follicles remains very low, questioning the relevance of providing LH activity to improve oocyte maturation during IVM cycles performed for FP. The present investigation aimed to test whether the absence of therapeutic intervention prior to oocyte retrieval modifies IVM outcomes when compared with cycles primed either with recombinant hCG or GnRH agonist in breast cancer patients.

Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients

Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients: a Randomized Controlled Study

Total number of mature oocytes obtained and cryopreserved after IVM

Total number of COCs recovered after COCs retrieval

ratio between the number of mature oocytes over the number of COCs recovered

Hôpital Jean Verdier

Professor

Ovarian Hyperstimulation Syndrome

Vasoconstrictor Agents

Endothelial Growth Factors

Mitogens

Angiotensin II

Giapreza

Angiotensinogen

This research is to investigate the response of vascular active factors, vascular endothelial growth factor (VEGF) and angiotensin-Ⅱ (AT-Ⅱ) to ovary stimulation during 24h in patients with polycystic ovary syndrome (PCOS).Controled prospective clinical study involved 60 women undergoing in vitro fertilization. Fifty-two patients with PCOS and 8 control cases were stimulated with human chorionic gonadotropin (HCG) during the early follicular phase of the menstrual cycle (4st to 7th days of the cycle).The blood was sampled before the injection (0 hour) and at the 3, 6, 12, 18 and 24 hours points after the stimulation. VEGF, AT-Ⅱ were measured by radioimmunoassay.

After ovary stimulation, the level of VEGF in typical PCOS patients is obviously increased at the 3hs time point (p\<0.05), while there is no difference with VEGF at all other time point among the four groups. As for AT-Ⅱ, before and after the ovary stimulation, at all time points, the AT-Ⅱ levels in serum of patients with different phenotypes of PCOS by Rotterdam criteria are all higher than the controls without PCOS. After the ovary stimulation, AT-Ⅱ in typical PCOS patients is obviously increased at 3hs time point, p\<0.05. The response of VEGF and AT-Ⅱ to HCG in women with typical PCOS is higher in 24 hours after the stimulation during the early follicular phase. The response to the stimulation is different in patients with different phenotypes of PCOS by Rotterdam criteria. Serum VEGF and AT-Ⅱ levels as a possible contributor to a great risk of developing OHSS in patients with typical PCOS during the early follicular phase in 24 hours after the ovary stimulation.

Response of VEGF and AT-II to HCG in PCOS

The Higher Response of Vascular Endothelial Growth Factor and Angiotensin-II to Human Chorionic Gonadotropin in Women With Polycystic Ovary Syndrome

Nanjing University School of Medicine

Associate Professor

Infertility

Anticoagulants

Other Dietary Supplements

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Calcium

Calcium, Dietary

Chelating Agents

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Citrate

Women will receive clomiphene citrate and human chorionic gonadotropin (HCG)

Women will receive clomiphene citrate alone

Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle)

Clomiphene citrate and Human chorionic gonadotropin (HCG)

Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)

Clomiphene citrate

Mahmoud Thabet, MD

Khaled S Ismael, MD

Ahmed Ragab, MD

Maged R Elshamy, MD

Mohamed A Elnegery, MD

Hamed Youssef, MD

Mahmoud M Abdel-razik, MD

Mohamed S Abdelhafez, MD

The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).

Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of HCG and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle

Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS

Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

Number of ovulatory cycles divided by the number of stimulation cycles

Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation

Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation

Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women

Incidence of OHSS within 9 days of final triggering of oocyte maturation

Mohamed Sayed Abdelhafez

Ovitrelle will be injected in 35 asymptomatic women with BRCA1 or BRCA2 mutation during 90 days (an extra 4 weeks in a subgroup). The gene expression of the breast epithelial cells will be characterized and compared to the gene expression of the breast epithelial cells before ovitrelle injection.

Ovitrelle

Jose Russo, Prof.

Specific aim: To establish the proof of principle that treatment of "high breast cancer risk" women with recombinant human chorionic gonadotropin (r-hCG) will change their breast epithelium's high risk genomic profile to one similar to that identified in women with a history of early full first term pregnancy.

This study is based on the investigators preclinical data that have demonstrated that r-hCG exerts a mammary cancer preventive effect that is mediated by the induction of gland differentiation, which results in permanent changes in the genomic signature of this organ. This exploratory study will evaluate the genomic profile of breast epithelial cells obtained from random periareolar fine needle aspiration (RPFNA) specimens performed in high risk women treated for 90 days (an extra 4 weeks in a subgroup) with r-hCG. This knowledge will serve as the basis for establishing a novel genomic biomarker that will serve as a surrogate endpoint in future preventive clinical trials.

The objective of the proposed study is to characterize the genomic profile of breast epithelial cells obtained from 35 asymptomatic high breast cancer risk nulliparous premenopausal women carriers of BRCA1 and BRCA2 deleterious mutations. Gene expression measurements and benign breast tissue specimens will be obtained at baseline (time 0), after treatment with r-hCG at 90 days (time 1), at 270 days from baseline (time 2) and (in a subgroup) at 60 weeks (+/- 4 weeks).

The primary objective of the study is to compare the gene expression profiles of these women across the three (or four) time points and identify differentially expressed genes. The investigator is interested in comparing the expression profiles between all pairs of time points as well as across time. The comparison of profiles before and after treatment with r-hCG, both at 90 and 270 days are of particular interest. The women will receive 3x/week injections of 250 microgram r-hCG for a total of 12 weeks (an extra 4 weeks in a subgroup). Core Needle Biopsies specimens will be primarily utilized for analysis of genomic expression by cDNA microarray. In addition, a series of surrogate intermediate markers such as cytomorphologic evaluation and cell proliferation index will be analyzed.

Only females who are BRCA1 or BRCA2 carriers and who are premenopausal will be included

Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers

The Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers

The investigators are expecting that r-hCG is inducing genomic signature of protection in the breast. Participants will receive a subcutaneous injection of recombinant hCG three times a week for 12 (or 16) weeks. Normal breast tissue specimens will be collected by Spirotome at the beginning of treatment (day 0), at the end of treatment (week 13) and at 36 weeks. The specimens will be primarily utilized for analysis of genomic expression by cDNA microarray, RNA sequencing and epigenomic studies. In addition, a series of surrogate intermediate markers such as cytomorphologic evaluation and cell proliferation index will be analyzed. The primary objective is to compare the gene expression, and epigenomic profiles of sampled breast epithelial cells across the three time points and identify differentially expressed or silenced genes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ovarian Morphology and Theca Cell Androgen Production in Women With Polycystic Ovary Syndrome (PCOS)	NCT02145247	Polycystic Ovar...	hCG	18 Years - 37 Years	University of California, San Diego
Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women	NCT00808522	Breast Cancer	hCG	30 Years - 75 Years	New York Presbyterian Hospital
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients	NCT03954197	Fertility Prese... Breast Cancer	No hormone hCG GnRH a	18 Years - 38 Years	Hôpital Jean Verdier
Response of VEGF and AT-II to HCG in PCOS	NCT02265861	Polycystic Ovar...	HCG	21 Years - 35 Years	Nanjing University School of Medicine
Prevention of Breast Cancer: As Simple as hCG-A Randomized Clinical Trial in High Risk Women	NCT00808522	Breast Cancer	hCG	30 Years - 75 Years	New York Presbyterian Hospital
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients	NCT03954197	Fertility Prese... Breast Cancer	No hormone hCG GnRH a	18 Years - 38 Years	Hôpital Jean Verdier
Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS	NCT02436226	Infertility Polycystic Ovar...	Clomiphene citr... Clomiphene citr...	20 Years - 35 Years	Mansoura University
Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers	NCT03495609	hCG BRCA1 Mutation BRCA2 Mutation	Ovitrelle	18 Years - 30 Years	University Hospital, Ghent

Spots Global Cancer Trial Database for hcg

Every month we try and update this database with for hcg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hcg

Every month we try and update this database with for hcg cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hcg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.