Comparison of Progesterone based stimulation with conventional protocol during the luteal phase of menstrual cycle in poor ovarian responders undergoing dual stimulation (DuoStim)

Progesterone-primed versus conventional antagonist stimulation during the luteal phase in poor ovarian responders undergoing Duo-Stim protocol- a pilot study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064504

Enrollment

Registered

2024-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: N979- Female infertility, unspecified

Interventions

Intervention1: Oral Progesterone: Oral progesterone ( Medroxyprogesterone acetate) will be used to suppress LH surge in patients undergoing ovarian stimulation in the luteal phase. It will be started

Eligibility

Inclusion criteria

Inclusion criteria: Women with defined decreased ovarian reserve before stimulation: Patients meeting any two of the following criteria: Age greater than 35 years, AMH less than 1.2, AFC less than 5 Unexpected poor response ,despite normal ovarian reserves, to ovarian stimulation in previous cycles: Less than 4 oocytes retrieved in previous IVF/ICSI cycles Unexpected suboptimal response, despite normal ovarian reserves, to ovarian stimulation in previous cycles: 4to 9 oocytes retrieved in previous IVF ICSI cycles Willing to participate in the study Women meeting the above-mentioned criteria and having at least two follicles in each ovary between 2-8 mm at the time of ovum pickup after follicular stimulation, will be taken up for subsequent luteal phase stimulation.

Exclusion criteria

Exclusion criteria: Diagnosed PCOS Severe male factor infertility,requiring surgical sperm retrieval or severe OATS Donor Recipient Cycles BMI less than 19 kg/m2 or greater than 30 kg/m2 Any history of genital tuberculosis Unwilling to participate in the study

Design outcomes

Primary

Measure	Time frame
Number of oocytes retrieved Number of Metaphase-II (M-II) oocytes retrieved Timepoint: Baseline (On the day of ovum pickup)	—

Secondary

Measure	Time frame
Total dose of gonadotropins required Duration of controlled ovarian stimulation Serum estradiol (E2) & progesterone (P4) on the day of trigger Fertilization Rate Cleavage Rate Blastulation Rate Cycle cancellation rate Clinical Pregnancy Rate per embryo transfer Cumulative clinical pregnancy rate Cumulative live birth rate (CLBR) Timepoint: Total dose of gonadotropins required, Duration of controlled ovarian stimulation, Serum estradiol (E2) & progesterone (P4) on the day of trigger will be assessed at baseline. Fertilization Rate,Cleavage Rate,Blastulation Rate,Cycle cancellation rate will be assessed at a single time point on day 5/day 6 post ovum pickup Clinical pregnancy rate will be assessed 6-8 weeks after embryo transfer	—

Measure

Time frame

Total dose of gonadotropins required Duration of controlled ovarian stimulation Serum estradiol (E2) & progesterone (P4) on the day of trigger Fertilization Rate Cleavage Rate Blastulation Rate Cycle cancellation rate Clinical Pregnancy Rate per embryo transfer Cumulative clinical pregnancy rate Cumulative live birth rate (CLBR) Timepoint: Total dose of gonadotropins required, Duration of controlled ovarian stimulation, Serum estradiol (E2) & progesterone (P4) on the day of trigger will be assessed at baseline. Fertilization Rate,Cleavage Rate,Blastulation Rate,Cycle cancellation rate will be assessed at a single time point on day 5/day 6 post ovum pickup Clinical pregnancy rate will be assessed 6-8 weeks after embryo transfer

—

Countries

India

Contacts

Public ContactSnigdha Soni

All India Institute of Medical Sciences, New Delhi

malhotraneena@yahoo.com9891557707

Outcome results

None listed

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