Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

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All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Follicle Stimulating Hormone

Leuprolide

Progesterone

Chorionic Gonadotropin

Menotropins

Hormones

Progestins

Hormone Antagonists

Antineoplastic Agents, Hormonal

Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Follitropin beta (Follistim Pen®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Follitropin beta (Follistim Pen®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.

Menotropin

100 mg inserted vaginally 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.

Progesterone vaginal insert

Follitropin beta

50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.

Progesterone in oil

Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.

leuprolide acetate

Clinical Development Support

This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.

Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients

A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).

The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.

The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.

The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.

The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells.

Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape.

The number of embryos that were not transferred but instead were frozen for future use.

Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.

Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.

Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.

Blood tests were sent to a central laboratory to obtain hCG levels.

Blood tests were sent to a central laboratory to obtain progesterone levels.

Number of live births resulting from the IVF process

Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:

mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.

Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.

Ferring Pharmaceuticals

Multiple events in the same system organ class for a subject are only counted once for that system organ class.

Menotropin/Progesterone Vaginal Insert

Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Menotropin/Progesterone in Oil

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Follitropin Beta/Progesterone Vaginal Insert

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Follitropin Beta/Progesterone in Oil

Total

Age, Categorical

Sex: Female, Male

Caucasian

African American

Asian

Hispanic

Other

Race/Ethnicity, Customized

Comparing Progesterone vaginal insert to Progesterone in oil within the menotropin treatments arms.

Comparing Progesterone vaginal insert to Progesterone in oil within the follitropin beta treatment group.

Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication

Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3

Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil.

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil.

Follitropin Beta

Number of Follicles Observed at Day 15

Number of Oocytes Retrieved at Day 18

Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved

Number of embryos transferred

Number of morula transferred

Number of blastocyst transferred

Number of Embryos Transferred at Three Stages of Development Before Implantation

Number of Embryos Frozen

Percentage of Participants With Biochemical Pregnancy at Approximately Day 38

Percentage of Participants With Clinical Pregnancy at Week 7

Percentage of Participants With Ongoing Pregnancy at Week 9

Estradiol Levels at Day 6

Human Chorionic Gonadotropin (hCG) Levels at Day 6

Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration

Database was locked prior to most participants giving birth.

Number of Live Births Resulting From the In Vitro Fertilization Process

With at least one adverse event

With at least one mild or moderate adverse event

With at least one severe adverse event

With at least one serious adverse event

With at least one unrelated or unlikely AE

With at least one possibly or probably related AE

Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study

Participants With Treatment Emergent Adverse Events

Overall Study

Mitogens

Triptorelin Pamoate

Cetrorelix

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

The pituitary down-regulation in this group will be carried out using 0.05-0.1 mg of Triptorelin acetate subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the menstrual cycle until the ovulation triggering day. When the suppressive effect is obtained, ovarian stimulation will commence with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) and the dose will be adjusted according to the ovarian response. Ovulation will be triggered by the administration of 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI).

The ovarian stimulation in this group will be started with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) on the third day of the menstrual cycle and the dose will be adjusted according to the ovarian response. Initiation of 0.25 mg of GnRH antagonist; Cetrorelix; will take place after detecting a leading follicle diameter ≥ 14 mm. GnRH antagonist administration will be continued till the day of ovulation triggering, which will be accomplished by given 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI).

0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.

Triptorelin acetate

0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.

Dosage adjustment according to the ovarian response.

recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin

Ovulation will be triggered by the administration of 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm.

Human Chorionic Gonadotropin (hCG)

Sally Kadoura, B Pharm, MD

Abdul Hakim Nattouf, MD, PhD

Marwan Alhalabi, MD, PhD

This prospective, non-randomised, open-label, clinical trial is conducting on polycystic ovary syndrome (PCOS) subjects to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on clinical and embryological IVF/ICSI outcomes, and on the follicular fluid levels of Placental Growth Factor (PlGF); which is known for his pivotal role in the regulation of ovulation, embryo development, and implantation

Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until assayed using an Elisa kit.

The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration 35±2 hours after hCG administration.

The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.

Maturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes.

Fertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes.

Cleavage rate is calculated by dividing the number of cleavaged embryos by the number of zygotes (2PN).

Embryos are assessed using Nikon SMZ1500 stereoscope based on ESHRE criteria (2011).

High Quality Embryos rate is calculated by dividing the number of high quality embryos (Grade I) by the total number of cleavaged embryos.

Biochemical pregnancy is defined as a positive serum beta-hCG pregnancy test after 2 weeks of embryo transfer. The biochemical pregnancy rate is calculated by dividing the number of women who are biochemically pregnant by the number of women who have at least 1 embryo transferred.

Clinical pregnancy is defined as the presence of a gestational sac on ultrasound after 3-4 weeks of embryo transfer. The clinical pregnancy rate is calculated as by dividing the number of women who are clinically pregnant divided by the number of women who have at least 1 embryo transferred.

Damascus University

Nervous System Diseases

Pituitary Diseases

Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal

Pituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2\<40pg/ml in serum, was initiated during the luteal phase

Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal phase

Long-acting Triptorelin

Short-acting Triptorelin

Jianjun Zhou, Doctor

Jianjun Zhou, Dcotor

To test whether long-acting Triptorelin on pituitary down-regulation can improve the clinical pregnancy rate and reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovaries (PCOs) who underwent in vitro fertilization (IVF) or Intracytoplasmic sperm injection

All patients received standard ovarian stimulation with rFSH under pituitary suppression with GnRH agonist according to a protocol used routinely. The long-acting Triptorelin group use long-acting Triptorelin 1.875mg during the luteal phase on Pituitary down-regulation , the Short acting Triptorelin use short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2\<40pg/ml in serum, was initiated during the luteal phase. Gonadotrophin stimulation of the ovaries was started when serum E2 concentrations declined to \< 40 pg/ml and a vaginal ultrasonographic scan showed an absence of follicles \> 10mm diameter. Ovarian stimulation was started wih 150-250 IU/day of recombinant FSH (Gonal F, Serono, Switzerland); the initial dose was determined by clinical judgement of the clinician according to the patients's age, body mass index, basal FSH and E2. Transvaginal ultrasound and E2 measurement were used to monitor follicular growth, and gonadotropin dosages were adjusted accordingly. Ovulation was triggered by intramuscular administration of 5000-10,000 IU of human chorionic gonadotropin (HCG, Ferring Pharmaceuticals) when at least two follicles reached a diameter of 18 mm. Serum HCG value were measured at 12 h after HCG trigger using the immunoassay. Oocytes were retrieved 36 h after the injection of HCG.

Comparative Study of Long-acting and Short Acting Triptorelin in PCOS Patients Who Underwent IVF/ICSI

Comparative Study of Long-acting and Short Acting Triptorelin on Pituitary Down-regulation in Long Protocol in PCOS Patients Who Underwent IVF/ICSI Treatment

compare the cinical pregnancy rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment

compare the moderate/severe OHSS rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment

Nanjing University

Reproductive Medicine Center, Drum Tower Hospital Affiliated to Nanjing University Medical College

Micronutrients

Hematinics

Vitamins

Other Dietary Supplements

Inositol

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

standard ovarian stimulation and Inofolic®

standard ovarian stimulation without Inofolic®

Inofolic®

Gonadotropins; Folic Acid

Fabienne DELAY, PH

The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients.

The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)	NCT00805935	Polycystic Ovar... Infertility	Menotropin Progesterone va... Follitropin bet... Progesterone in... leuprolide acet...	18 Years - 42 Years	Ferring Pharmaceuticals
Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.	NCT04727671	In Vitro Fertil... Intracytoplasmi... Infertility Polycystic Ovar...	Triptorelin ace... Cetrorelix recombinant-FSH... Human Chorionic...	18 Years - 39 Years	Damascus University
Comparative Study of Long-acting and Short Acting Triptorelin in PCOS Patients Who Underwent IVF/ICSI	NCT02477566	In Vitro Fertil... Polycystic Ovar...	Long-acting Tri... Short-acting Tr...	22 Years - 35 Years	Nanjing University
Comparative Study of Long-acting and Short Acting Triptorelin in PCOS Patients Who Underwent IVF/ICSI	NCT02477566	In Vitro Fertil... Polycystic Ovar...	Long-acting Tri... Short-acting Tr...	22 Years - 35 Years	Nanjing University
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)	NCT02221154	Polycystic Ovar...	Inofolic® Gonadotropins; ...	18 Years - 38 Years	Centre Hospitalier Departemental Vendee
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)	NCT00805935	Polycystic Ovar... Infertility	Menotropin Progesterone va... Follitropin bet... Progesterone in... leuprolide acet...	18 Years - 42 Years	Ferring Pharmaceuticals
Liraglutide and Metformin Combination on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With PCOS, Obesity and Infertility	NCT05952882	Polycystic Ovar... Obesity Infertility, Fe...	Liraglutide + M... Metformin	18 Years - 65 Years	Mỹ Đức Hospital
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)	NCT02221154	Polycystic Ovar...	Inofolic® Gonadotropins; ...	18 Years - 38 Years	Centre Hospitalier Departemental Vendee
Polycystic Ovary Syndrome (PCOS) and In Vitro Fertilization (IVF): A Comparison Between Standard Long Protocol Versus an Antagonist Protocol Starting on Day 1	NCT00883766	Polycystic Ovar... In Vitro Fertil...	Controlled ovar... Controlled ovar...	18 Years - 37 Years	Institut Universitari Dexeus
Vitamin D and Pregnancy Outcome in PCOS Patients	NCT04082650	Polycystic Ovar... in Vitro Fertil...	vitamin D Placebo	20 Years - 42 Years	Women's Hospital School Of Medicine Zhejiang University

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