Comparison of new progestin based IVF treatment with standard GnRH antagonist based IVF treatment in Polycystic ovarian syndrome (PCOS) women

Comparison of flexible progestin-primed ovarian stimulation protocol (PPOS) with flexible GnRH antagonist protocol in polycystic ovary syndrome (PCOS) women undergoing IVF/ICSI cycles: A pilot randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071226

Enrollment

Registered

2024-07-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Flexible Progestin primed ovarian stimulation: In the ovarian stimulation cycle medroxyprogesterone acetate 10 mg orally daily will be added when the leading follicle is = 12 mm size a

Eligibility

Inclusion criteria

Inclusion criteria: BMI less than 35kg/m2 with PCOS diagnosed as per the International PCOS guidelines. Diagnosis of PCOS is made if after excluding other causes of irregular menstrual cycle and hyperandrogenism, any two of the following is present: 1. Irregular menstrual cycles-oligomenorrhoea/ amenorrhoea; 2. Clinical/biochemical hyperandrogenism; 3. Polycystic ovarian morphology –Defined on TVS as (FNPO) follicle number per ovary equals/ exceeds 20 in atleast one ovary.

Exclusion criteria

Exclusion criteria: Grade 3 or higher endometriosis Uterine anomalies, fibroid or adenomyoma distorting the endometrial cavity Uncontrolled thyroid and/or prolactin disorders Not willing to participate in study

Design outcomes

Primary

Measure	Time frame
Premature LH surge and Oocyte yield Timepoint: 4-5 weeks	—

Secondary

Measure	Time frame
Total dose of gonadotropins required Duration of controlled ovarian stimulation Peak serum estradiol (E2), progesterone (P4) and luteinizing hormone (LH) level on the day of trigger Number of total/MII oocytes retrieved FORT (Follicular output rate) FOI (follicular oocyte index) Fertilization rate Cleavage rate Clinical pregnancy rate Incidence of OHSS Timepoint: 2 years	—

Countries

India

Contacts

Public ContactProf Reeta Mahey

All India Institute of Medical Sciences

drreetamahey@gmail.com9818447845

Outcome results

None listed

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