Protocols of IVF/ICSI in Poor Responders

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356105
• Other study ID #: 12020
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Minimal stimulation protocol
Letrozole, Recombinant FSH, GnRH antagonist
• Microflare protocol
OCP, GnRH agonist, Recombinant FSH

Procedure:
• IVF/ICSI cycle
Involving ovum pickup and embryo transfer

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo
Egypt	IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cancellation rate	Number of cycles not reaching ovum pickup	10 to 14 days
Other	Total dose of recombinant FSH	The mean total dose of recombinant FSH used in the cycle of treatment	10 to 14 days
Primary	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	Number of MII oocytes retrieved	The mature oocytes colloected on the day of ovum pickup	10 to 14 days
Secondary	Number of fertilized oocytes	Number of oocytes fertilized	2 days
Secondary	Number of embryos transferred	Number of embryos transferred in the induction cycle	Day 3 after ovum pickup
Secondary	Number of embryos cryopreserved	Any surplus good quality embryos available for cryopreservation	Day 3 after ovum pickup
Secondary	Chemical pregnancy rate	Positive pregnancy test	14 days after embryo ransfer
Secondary	Clinical pregnancy rate	Positive heart beat	5 to 7 weeks after embryo transfer
Secondary	Early miscarriage rate	loss of pregnancy before 12 weeks	12 weeks
Secondary	Ongoing pregnancy rate	pregnancy beyond 12 weeks	12 weeks
Secondary	Live birth rate	Delivery beyond 28 weeks	28 to 40 weeks