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Options to Increase IVF Success

To compare the Safety and Efficacy of Repeated GnRH agonist injections versus rescue hCG for modified Luteal Phase Support in predicted hyper-responders undergoing IVF cycles: A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063849
Enrollment
100
Registered
2024-03-08
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: Z318- Encounter for other procreative management

Interventions

Intervention1: Injection leuprolide acetate: Dose- 0.5 mg Frequency - once a day on day 3, 5, 7, 9 and 11 of ovum pick up Route- subcutaneous total duration- 5 injections on day 3, 5, 7, 9 and 11 of

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Predicted hyper-responders: fulfilling either of the three criteria, a. AFC more than 16,b. more than 13 follicles of more than 11 mm on day of GnRH agonist trigger, c.Serum estradiol levels more than 3500 pg per ml on day of trigger GnRH antagonist cycles Women aged 22 to less than 40 years Unexplained infertility Anovulatory infertility Mild to moderate male factor infertility

Exclusion criteria

Exclusion criteria: more than 25 oocytes retrieved at ovum pick up Signs of early onset OHSS Any other contraindication to fresh ET Known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the endometrial cavity, Asherman’s syndrome, thrombophilia or endometrial tuberculosis) Previous 2 or more failed IVF Patients who do not give written informed consent to participate BMI less than 18 or more than 30Kg per m2 Cycles with frozen spermatozoa or oocytes Oocyte donation cycles Uterine anomalies

Design outcomes

Primary

MeasureTime frame
Primary Outcome: Clinical pregnancy rate (Number of clinical pregnancies as determined by visualization of fetal cardiac activity on transvaginal ultrasound at 6–7weeks of gestation per embryo transfer cycles).Timepoint: at 6–7weeks of gestation per embryo transfer cycles

Secondary

MeasureTime frame
Ovarian hyperstimulation rate (OHSS rate) Hormonal dynamics (Serum LH, Progesterone (P4), Estradiol(E2) on day of ovum pick up ( day 0) , day 3, day 7 & day 14) Implantation rate : defined as number of intrauterine sac with a fetal cardiac activity determined by transvaginal ultrasound by total number of transferred embryos. Ongoing pregnancy rate defined as number of viable pregnancies beyond 12 weeks of gestation per embryo transfer Miscarriage rate defined as loss of pregnancy before 24weeks of gestation was Live birth rate : delivery of a viable fetus past 24weeks of gestation. Cancelled embryo transfer rateTimepoint: Hormonal dynamics (Serum LH, Progesterone (P4), Estradiol(E2) on day of ovum pick up ( day 0) , day 3, day 7 & day 14) Ongoing pregnancy rate defined as number of viable pregnancies beyond 12 weeks of gestation per embryo transfer Miscarriage rate defined as loss of pregnancy before 24weeks of gestation was Live birth rate : delivery of a viable fetus past 24weeks of gestation

Countries

India

Contacts

Public ContactDr Archana Kumari

All India Institute of Medical Science

malhotraneena@yahoo.com9891557707

Outcome results

None listed

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