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Comparison of efficacy of coadministration of oral ovulation induction drugs to conventional ovarian stimulation protocol in infertile women with diminished ovarian reserve undergoing IVF or ICSI cycles

Efficacy of coadministration of clomiphene citrate and letrozole to conventional GnRH antagonist protocol in expected poor responders undergoing IVF or ICSI cycles A Randomized Controlled Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082363
Enrollment
212
Registered
2025-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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: Clomiphene citrate plus Letrozole group: In this group, patients will receive oral tablet Clomiphene citrate (100 mg) and tablet Letrozole (5 mg) from day 2 to day 6 of menses along wit

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: BMI of less than 35kg/m2, unexplained infertility, tubal factor, mild male infertility, willing to participate in study

Exclusion criteria

Exclusion criteria: Women with diagnosed PCOS, Endometrioma of size more than 3 cm, fibroid or adenomyoma distorting the endometrial cavity, severe male factor infertility (oligoasthenoteratozoospermia)

Design outcomes

Primary

MeasureTime frame
Number of Grade 1 oocytes (Expanded cumulus, very radiant corona, distinct zona pellucida, clear ooplasm, expanded well aggregated membrana granulosa cells)Timepoint: once during IVF or ICSI Cycle—

Secondary

MeasureTime frame
Total dose of gonadotropins required Duration of stimulation Peak estradiol & progesterone on the day of trigger Number of oocytes retrieved Number of mature oocytes retrieved Mature oocyte output rate (MOOR) Number of follicles more than 14 mm on the day of trigger Follicular output rate (FORT) Endometrial thickness on the day of trigger Fertilization rate Cleavage rate Blastulation rate Cycle cancellation rate Clinical pregnancy rate per embryo transfer Cumulative clinical pregnancy rate Timepoint: During IVF or ICSI cycle- Ovum pick up and Embryo transfer—

Countries

India

Contacts

Public ContactDr Nishtha Jaiswal

All India Institute of Medical Sciences

drreetamahey@gmail.com9818447845

Outcome results

None listed

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