hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF

Study Overview
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Brief Summary
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There have been some controversies regarding the use of preparations with LH activity in patients with polycystic ovary syndrome (PCOS) who have high endogenous LH activity. In this research we aimed to compare urinary menotrophin versus recombinant FSH (rFSH) with respect to the prevention of OHSS

Detailed Description
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Polycystic ovary syndrome was diagnosed according to the Rotterdam criteria. Patients older than 38 years or with serum FSH level ≥12mIU/ml and a history of ovarian surgery were excluded from the study. All of our patients were given combined oral contraceptive (Yasmin) prior to ovulation induction cycles. Leuprolide Acetate (Lucrin daily; Abbott, Istanbul) therapy was started in mid-luteal phase to induce pituitary down regulation, and was initiated at a dose of 1.0 mg SC daily until pituitary down-regulation was established. The leuprolide acetate dose was then reduced to 0.5 mg daily until the day of human chorionic gonadotropin (hCG) administration. After GnRH analogue suppression was achieved, the patients were randomized using block randomization (block of two) to stimulation with hMG (Menogon; Ferring Pharmaceuticals. Istanbul) or rFSH (Gonal-F; Serono Istanbul). Starting dose was 150IU for the first 3 days of stimulation, after which daily dosing was determined individually. Serial Estrodiol (E2) levels and two-dimensional follicle measurements by transvaginal ultrasonography (LOGIC 200 PRO, General Electric, Korea) were performed until at least two dominant follicles reached dimensions of 18 mm or greater in diameter. Human chorionic gonadotropin (Pregnyl, Organon, 10,000 IU- IM) was then administered, followed by transvaginal oocyte retrieval 36 hours later. The criteria of coasting in our institute were serum E2 >3600 pg/ml and multiple intermediate follicle. During coasting period, gonadotropin was withheld, but leuprolide acetate was continued at 0.5mg/d. ICSI was performed for all the patients. Fertilization was assessed at 20h (±1h), and embryo quality was assessed at 28, 44, and 68h (±1h) after oocyte retrieval. A top- quality embryo was defined as four to five cells on day 2, seven or more cells on day 3, and no multinucleation. Vaginal progesterone gel 90 mg/day 8% (Crinone;Serono) for luteal support was given from the oocyte retrieval until the clinical pregnancy (9-10 weeks of gestation) or negative serum βhCG test (13-15 days after embryo transfer).

Official Title
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Influence of Ovarian Stimulation With hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: HMG
* Drug: rFSH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with PCOS Exclusion Criteria: Patients older than 38 years or with serum FSH level ≥12mIU/ml and a history of ovarian surgery were excluded from the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: menotrophin<br>In this prospective trial, women with PCOS (according to Rotterdam criteria) were randomized (80 patients) after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles. | Drug: HMG<br>* In this prospective trial, women with PCOS (according to Rotterdam criteria) were randomized (80 patients) after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.<br>* Other names: Menotrophin;|
| Active Comparator: recombinant FSH<br>Patients were randomized after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles. | Drug: rFSH<br>* Patients were randomized after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of OHSS |  | 6 Months | 
| peak serum E2 levels |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the need of coasting, |  | 6 months | 
| number of intermediate follicles |  | 6 months | 
| fertilization rate |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HMG, ICSI, OHSS, PCOS, recFSH, IVF