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Arvekap 0.1mg (Triptorelin, Ipsen, France)

Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)

Tryfon Lainas, PhD

The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the occurrence and severity of OHSS compared to the GnRH agonist protocol.

Women with polycystic ovarian syndrome (PCOS) represent a group of patients at high risk of developing ovarian hyperstimulation syndrome (OHSS), an iatrogenic complication of ovarian stimulation during IVF treatment. In contrast to mild OHSS, severe OHSS is a life-threatening complication, characterized by massive ovarian enlargement, ascites, pleural effusion, oliguria, haemoconcentration and thromboembolic phenomena. Currently, no curative therapy for OHSS is available and thus prevention is considered the most effective "treatment". Several measures have been adopted to reduce the occurrence of the syndrome, the most effective being cycle cancellation and withholding of human chorionic gonadotropin (hCG), which seems to be the most critical factor for the development of OHSS.

COMPARISON: This study aims to compare the development and severity of OHSS, as well as ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist (Ganirelix) protocol vs a long GnRH agonist (Arvekap) protocol of ovarian stimulation.

Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients

Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients

Eugonia

Anti-Dyskinesia Agents

Cardiotonic Agents

Cabergoline

Antiparkinson Agents

Dopamine

Dopamine Agonists

Dopamine Agents

Neurotransmitter Agents

The patients in this group will have cabergoline (Dostinex tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days) for prevention of OHSS.

All patients were administered long luteal protocol for ovulation induction.

The patients in the control group had no manipulation for prevention of OHSS and age-, BMI-matched with the active comparator group.

All patients were administered long luteal protocol for ovulation induction.

Cabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days

Emine Seda Guvendag Guven, MD

Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome (OHSS).

Dopamine agonists have been proposed as a prophylactic treatment for OHSS in women with high risk of OHSS, however the possible mechanism of action has not been clearly known. In experimental studies, inhibition of vascular endothelial growth factor based pathway was proposed as a possible action of mechanism of dopamine agonists. However the role hepatocyte growth factor (HGF), insulin like growth factor-I (IGF-I), inhibin B and antimullerian hormone (AMH) on cabergoline action in OHSS prevention has not been known.

Ovarian Hyperstimulation Syndrome and Cabergoline

The Effect Of Cabergoline On Follicular Microenvironment Profile In Patients With High Risk Of Ohss

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Assoc. Prof.

Anticoagulants

Other Dietary Supplements

Estradiol

Follicle Stimulating Hormone

Citric Acid

Sodium Citrate

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Cetrorelix

Progesterone

Clomiphene

Enclomiphene

Zuclomiphene

Chorionic Gonadotropin

Menotropins

Citrate

The group of minimal ovarian stimulation that will receive 100 mg clomiphene citrate every day from Day 3 to Day 7 of the menstrual cycle and then will be treated with 150 International Unit (IU) Gonal-f (Follitropin alfa, Merck Serono, Germany) after the seventh day.

The group of minimal ovarian stimulation that will receive 100 mg clomiphene citrate every day from Day 3 to Day 7 of the menstrual cycle and then will be treated with 150 IU Merional (Highly Purified Menotropin، IBSA، Switzerland) after the seventh day.

The group of mild ovarian stimulation that will receive 150 IU Gonal-f (Follitropin alfa, Merck Serono, Germany) daily from Day 3 of the menstrual cycle.

The group of mild ovarian stimulation that will receive 150 IU Merional (Highly Purified Menotropin، IBSA، Switzerland) daily from Day 3 of the menstrual cycle.

After obtaining informed consent to participate in the study, the subjects will be randomly divided into the following 4 groups: The group of minimal ovarian stimulation with rec-FSH or HMG. The group of mild ovarian stimulation with rec-FSH or HMG. In all 4 experimental groups, after reaching at least three follicles the size of 12 millimeters (mm), daily administration of 0.25 milligram (mg) Cetrotide (antagonist GnRH) will be started and after reaching at least three follicles the size of 17 mm, 500 microgram Ovitrelle (recombinant Human curionic gonadotropin) will be prescribed. 36 hours later, ovulation process will be done. On the day of Ovitrelle administration, serum levels of estradiol and progesterone will be also evaluated. Based on the patient's condition and the quality of obtained oocytes and embryos, 2 embryos will be transferred.

Minimal ovarian stimulation

Firoozeh Ghaffari, M.D.

Azar Yahyaei, M.Sc.

This study is a randomized controlled clinical trial to compare the pregnancy outcomes of mild and minimal stimulation in infertile women with polycystic ovarian syndrome. The study population consisted of all infertile women with polycystic ovary syndrome based on Rotterdam criteria who have not succeed to achieve fertility despite multiple treatments such as drug therapy, laparoscopic surgery, and the frequent failure of induction therapy using gonadotropins and are now candidate for in vitro fertilization (IVF) or intra cytoplasmic sperm injection (ICSI) in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

An overview of the history of assisted reproductive technologies such as IVF and ICSI that are based on the process of ovulation stimulation, suggests that although this process was initially welcomed with the aim of achieving a large number of oocytes and embryos, consequences such as low quality of obtained oocytes and embryos, failure in achieving the desired results in fertility of treated patients, and the incidence of adverse effects such as ovarian hyper stimulation syndrome have made researchers re-examine the process of ovulation stimulation. Hence, mild ovulation stimulation method has been introduced to the field of assisted reproductive techniques (ART) in recent years. This method includes the prescription of low doses of gonadotropins or shorter duration of its administration in the ovulation stimulation cycle. Mild ovulation method has advantages such as reduction of the physical, mental, and financial risks of treatment which can improve the quality assisted reproductive services provided for infertile couples.

Several studies have confirmed the efficiency of this method of ovulation stimulation as a way for improving the quality of the ovulation process and achieving desirable results in fertility. However, the important and interesting point in studies conducted in this area, particularly on IVF and ICSI cycles, is that the application of this method has been mostly investigated in normal populations and, after the approval of its efficiency, it has been recommended to be used in patients with poor or high ovarian response. It should be also mentioned that efficiency of this method in patients with poor ovarian response has been evaluated in a few studies, while in patients with high ovarian response such as those suffering from polycystic ovary syndrome, only few studies have been conducted in patients with a history of ovarian hyper stimulation syndrome. On the other hand, in many cases, the efficiency of mild ovulation stimulation, in which lower doses or shorter durations of gonadotropin administration are desired, has been investigated, and the application of minimal ovulation stimulation method, in which the use of clomiphene citrate is also included besides lower doses or shorter durations of gonadotropin administration, has been studied in a few cases.

In addition to the dose and duration of gonadotropin administration, another important point in achieving the desired results of treatment using the ovulation stimulation cycles is the type of gonadotropin. The studies conducted on the comparison of recombinant-FSH (rec-FSH) and Human Menopausal Gonadotropin (HMG) types of gonadotropin indicate the superiority of HMG gonadotropins, as the results show that the administration of HMG gonadotropins will lead to achieving fewer but high quality oocytes and embryos. By contrast, rec-FSH application puts the patients at increased risk of ovarian hyper stimulation syndrome. However, the interesting and important point in most of these studies is that this comparison has been drawn in long-term treatment cycles, while few studies have been conducted on antagonist treatment cycles which do not fully corroborate the results obtained from long-term cycles.

According to what mentioned above, the present research aims to study the efficiency of minimal ovulation stimulation method in the treatment of infertile patients with poly cystic ovarian syndrome (PCOS) and also the effect of gonadotropin type on treatment cycles with antagonist gonadotropin-releasing hormone (GnRH). It is hoped that the findings of the present research provide solutions for improving the quality of infertility treatment in PCOS patients, who currently undergo IVF or ICSI as a last resort.

The Four Methods of Ovarian Stimulation in Patients With Polycystic Ovarian Syndrome

A Comparison of Four Methods of Ovarian Stimulation With GnRH Antagonist in Patients With Polycystic Ovarian Syndrome in Royan Institute; A Randomized Controlled Clinical Trial

The ratio of 2 pronuclear to total number of injected oocytes.

The ratio of total number of observed gestational sacs to total number of transferred embryos.

The observation of gestational sac with heart beat by using trans-vaginal ultrasound.

Total number of cases with symptoms of ovarian hyper-stimulation syndrome.

Total number of obtained oocytes which reported by embryologist.

Total number of Meta-phase II oocytes which reported by embryologist.

Royan Institute

Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering

GnRH antagonist depot Degarelix

Mauro Schimberni, MD

PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.

Long Acting GnRH Antagonist in PCOS Women Undergoing IVF

The Use of a Long Acting GnRH Antagonist (Degarelix) in Controlled Ovarian Hyperstimulation in PCOS Women at a Risk to Developing OHSS Undergoing IVF : a Pilot Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients	NCT00417144	Polycystic Ovar... Ovarian Hyperst...	Arvekap 0.1mg (... Ganirelix 0.25m...	18 Years - 50 Years	Eugonia
Ovarian Hyperstimulation Syndrome and Cabergoline	NCT01569256	Polycystic Ovar... Ovarian Hyperst...	Cabergoline	23 Years - 35 Years	Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
The Four Methods of Ovarian Stimulation in Patients With Polycystic Ovarian Syndrome	NCT03876145	Polycystic Ovar... Ovarian Hyperst...	Minimal ovarian...	20 Years - 38 Years	Royan Institute
Long Acting GnRH Antagonist in PCOS Women Undergoing IVF	NCT02084940	Polycystic Ovar... Ovarian Hyperst... Invitro Fertili...	GnRH antagonist...	23 Years - 37 Years	Bioroma
Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients	NCT00417144	Polycystic Ovar... Ovarian Hyperst...	Arvekap 0.1mg (... Ganirelix 0.25m...	18 Years - 50 Years	Eugonia
Long Acting GnRH Antagonist in PCOS Women Undergoing IVF	NCT02084940	Polycystic Ovar... Ovarian Hyperst... Invitro Fertili...	GnRH antagonist...	23 Years - 37 Years	Bioroma

Spots Global Cancer Trial Database for ovarian hyperstimulation syndrome