Protocols of IVF/ICSI in Poor Responders

Phase 3

Completed

• Conditions: Infertility, Female
• Interventions: Drug: Microflare protocol; Drug: Minimal stimulation protocol; Procedure: IVF/ICSI cycle

• Registration Number: NCT04356105
• Lead Sponsor: Cairo University

Brief Summary

Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles

Detailed Description

The two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI cycles, primary outcome will be the number of oocytes retrieved.

Study Timeline

• Study First Submitted: 2020-04-18
• Study First Submitted QC: 2020-04-18
• Study First Posted: 2020-04-22
• Study Start: 2020-06-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:

1. Advanced maternal age
2. Previous poor ovarian response
3. Abnormal tests of ovarian reserve (AFC < 5-7, AMH <0.5-1.1 ng/ml)

Exclusion Criteria

1. Age > 43 years
2. baseline FSH >15 mIU/ml
3. Previous ovarian surgery
4. Ovarian endometrioma
5. Uterine anomaly or myoma
6. Any medical disorder
7. Any hormonal disorder eg. hyperprolactinemia
8. BMI > 30 kg/m2
9. Severe male factor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microflare Group	Microflare protocol	Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH
Minimal Stimulation Group	IVF/ICSI cycle	Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist
Minimal Stimulation Group	Minimal stimulation protocol	Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist
Microflare Group	IVF/ICSI cycle	Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	10 to 14 days	the number of oocytes collected from each participants in the two groups on the day of ovum pickup

Secondary Outcome Measures

Name	Time	Method
Number of embryos transferred	Day 3 after ovum pickup	Number of embryos transferred in the induction cycle
Live birth rate	28 to 40 weeks	Delivery beyond 28 weeks
Chemical pregnancy rate	14 days after embryo ransfer	Positive pregnancy test
Number of embryos cryopreserved	Day 3 after ovum pickup	Any surplus good quality embryos available for cryopreservation
Number of fertilized oocytes	2 days	Number of oocytes fertilized
Clinical pregnancy rate	5 to 7 weeks after embryo transfer	Positive heart beat
Ongoing pregnancy rate	12 weeks	pregnancy beyond 12 weeks
Number of MII oocytes retrieved	10 to 14 days	The mature oocytes colloected on the day of ovum pickup
Early miscarriage rate	12 weeks	loss of pregnancy before 12 weeks

Trial Locations

Locations (2)

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini); 🇪🇬 Cairo, Egypt

Cairo University; 🇪🇬 Cairo, Egypt