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Comparison of Two Ovarian Stimulation Protocols in Polycystic Ovarian Syndrome (PCOS) Patients Undergoing IVF/ICSI

Comparison of Ovarian Stimulation Cycle Outcome in Medroxy Progesterone Acetate and Gonadotropin Protocol with Antagonist and Gonadotropin Protocol in Polycystic Ovarian Syndrome Patients Undergoing In-Vitro fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080831001141N33
Enrollment
232
Registered
2021-01-01
Start date
2019-05-28
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovarian syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: Patients will receive rFSH (with or without HMG) at a dose of 150 to 225 IU/day and MPA 10 mg/day from day 3 of menstruation. Intervention 2: Control group: Patient

Sponsors

Royan Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 39 Years

Inclusion criteria

Inclusion criteria: The major criteria for diagnosis of PCOS are oligo and/or anovulation, clinical or biochemical signs of hyperandrogenism and polycystic ovaries; these criteria are in accordance with the revised 2003 Rotterdam criteria for PCOS Age between 18 to 39 years Body mass Index (BMI) less than 30 kg/m2

Exclusion criteria

Exclusion criteria: Clinically significant systemic disease such as renal failure Endometriosis grade 3 or higher Received hormonal treatments in the previous 3 months Any contraindications to ovarian stimulation Sever male factor (TESE-PESA)

Design outcomes

Primary

MeasureTime frame
Fertilization rate. Timepoint: 16-18 hours after sperm insemination or injection. Method of measurement: The ratio between the number of zygotes with two pronucleus and the injected oocytes.

Secondary

MeasureTime frame
Quality of retrieved oocytes including GV, MI, MII. Timepoint: Immediately after oocyte puncture. Method of measurement: GV: Germinal vesicle present in the ooplasm; MI: No visible GV in the ooplasm and no first polar body in the perivitelline space; MII: Small perivitelline space containing a single unfragmented first polar body.;Number of MII oocytes. Timepoint: Immediately after oocyte puncture. Method of measurement: Observation of oocytes that were mature at the time of oocyte collection.;OHSS occurrence. Timepoint: From puncture to subsequent mensturation. Method of measurement: Classification system according to the Navot scheme, including mild, moderate and severe forms.;Premature LH surge. Timepoint: During ovarian stimulation until the day of triggering. Method of measurement: Serum LH level of equally or more than 10 mIU or an increase of more than 2.5 times above the basal level.;Clinical pregnancy. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: The observation of gestational sac on ultrasound examination two-three weeks after positive serum ßhCG.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa Mostafaei

Royan Institute

mostafaeip@yahoo.com+98 21 2356 2645

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026