Efficacy of Low Dose hCG on Oocyte Maturity in Poor Responder Women Undergoing Intracytoplasmic Sperm Injection

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: rFSH; Drug: hCG

• Registration Number: NCT01509833
• Lead Sponsor: Royan Institute

Brief Summary

This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI) treatment.

Detailed Description

In this study all eligible patients were randomly allocated into three study groups by a permuted block randomization method: group A (control group) received only recombinant FSH, group B received rFSH supplemented by 100IU hCG in the late follicular phase. Group C received rFSH supplemented by 200IU hCG in the late follicular phase.

All of the patients underwent a standard long protocol and received GnRH-a (Suprefact), 0.5cc subcutaneous, started from the day 17 of the preceding cycle and ovulation induction was started 14 days thereafter.

Patients were categorized according to the following stimulation protocols:

Group A (control group): which 300 IU r-FSH was administered for the first 5 days of the stimulation cycle. Then the first ultrasound scan was performed to monitor response. At this stage the dose of rFSH adjusted according to the ovarian response and continued until the day of ovulatory hCG administration.

Group B: rFSH supplemented with daily administration of 100 IU hCG in the late follicular phase based on the follicle size (14mm).

Group C: rFSH supplemented with daily administration of 200 IU hCG in the late follicular phase based on the follicle size (14mm).

To assess the pregnancy outcomes, serum hCG was measured 2 weeks after embryo transfer. Clinical pregnancy was defined by the observation of sac with fetal heart rate on ultrasonography 4 weeks after embryo transfer.

Study Timeline

• Status Verified: 2009-08
• Study Start: 2009-10
• Primary Completion: 2011-03
• Study Completion: 2011-12
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-10
• Last Update Submitted: 2012-01-10
• Study First Posted: 2012-01-13
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

Inclusion Criteria

1. Poor ovarian response to ovulation induction according to the ESHRE definition[20] and presence of at least 2 of the criteria needed to define poor responders including advanced maternal age, history of low ovarian response in previous IVF/ICSI treatments and abnormal ovarian reserve test(Antral Follicle number < 5)
2. indication for ICSI treatment, second or third cycle
3. Age 37 to 43 years
4. Body mass index (BMI) ≤ 30 kg/m2
5. The presence of two functional ovaries and no previous ovarian surgery
6. The presence of normal uterine cavity and 2 normal tubes base on recent hysterosalpingographic or hysteroscopic evaluation
7. Basal (day 2 or 3) serum FSH levels ≤13 IU/L
8. Normal semen analysis
9. No history or signs of endometriosis
10. No untreated endocrinologic disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rFSH	rFSH	Administration of recombinant FSH for ovarian stimulation.
hCG(100IU)	hCG	Administration of late follicular low dose hCG(100U) for ovarian stimulation.
hCG(200IU)	hCG	Administration of late follicular low dose hCG(200IU) for ovarian stimulation.

Primary Outcome Measures

Name	Time	Method
Number of mature oocytes	Up to 2 hours after oocyte retrieval	Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval

Secondary Outcome Measures

Name	Time	Method
Number of retrieved oocytes	Up to 1 hour after oocyte retrieval	Evaluation the number of retrieved oocytes Up to 1 hour after oocyte retrieval
Number of generated embryos	Up to 48-72 hours after oocyte retrieval	Evaluation the number of generated embryos up to 48-72 hours after oocyte retrieval.
Quality of generated embryos	Up to 48-72 hours after oocyte retrieval	Evaluation the Quality of generated embryos up to 48-72 hours after oocyte retrieval.
Number of transferred embryos	on the time of embryo transfer	Evaluation the number of transferred embryos on the time of embryo transfer.
Quality of transferred embryos	on the time of embryo transfer	Evaluation the quality of transferred embryos on the time of embryo transfer.
implantation rate	4 weeks after embryo transfer	Evaluation the implantation rate 4 weeks after embryo transfer.
chemical pregnancy rates	2 weeks after embryo transfer	Evaluation the chemical pregnancy rates 2 weeks after embryo transfer.
clinical pregnancy rates	4 weeks after embryo transfer	Evaluation the clinical pregnancy rates 4 weeks after embryo transfer.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of