Protocols of IVF/ICSI in Poor Responders

Minimal Stimulation in a Combined Letrozole Antagonist Protocol Versus Microflare Protocol in Poor Responders Undergoing Invitrofertilization/ Intracytoplasmic Sperm Injection; Randomized Parallel Study

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

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: Minimal stimulation protocol; Procedure: IVF/ICSI cycle; Drug: Microflare protocol

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 Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University
  • Cairo, Egypt, 12311
    • IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Minimal Stimulation Group; Minimal dose stimulation ovarian induction protocol given to poor responders, involving letrozole, low dose recombinant FSH and GnRH antagonist	Drug: Minimal stimulation protocol; Letrozole, Recombinant FSH, GnRH antagonist; Other Names: Ovarian induction protocol; Procedure: IVF/ICSI cycle; Involving ovum pickup and embryo transfer
Active Comparator: Microflare Group; Microflare ovarian induction protocol given to poor responders, involving OCP, GnRH agonist, high dose recombinant FSH	Procedure: IVF/ICSI cycle; Involving ovum pickup and embryo transfer; Drug: Microflare protocol; OCP, GnRH agonist, Recombinant FSH; Other Names: Ovarian induction protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oocytes retrieved	the number of oocytes collected from each participants in the two groups on the day of ovum pickup	10 to 14 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancellation rate	Number of cycles not reaching ovum pickup	10 to 14 days
Total dose of recombinant FSH	The mean total dose of recombinant FSH used in the cycle of treatment	10 to 14 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Sarwat Ahwany, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: April 18, 2020
• First Submitted That Met QC Criteria: April 18, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 12020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No