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

Efficacy of Low Dose hCG on Oocyte Maturity for Ovarian Stimulation in Poor Responder Women Undergoing ICSI: a Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: rFSH; Drug: hCG; Drug: hCG

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 37 years to 43 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rFSH; Administration of recombinant FSH for ovarian stimulation.	Drug: rFSH; Administration of rFSH for ovarian stimulation.
Experimental: hCG(100IU); Administration of late follicular low dose hCG(100U) for ovarian stimulation.	Drug: hCG; Administration of late follicular low dose hCG(100IU) for ovarian stimulation.; Drug: hCG; Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
Experimental: hCG(200IU); Administration of late follicular low dose hCG(200IU) for ovarian stimulation.	Drug: hCG; Administration of late follicular low dose hCG(100IU) for ovarian stimulation.; Drug: hCG; Administration of late follicular low dose hCG(200IU) for ovarian stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of mature oocytes	Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval	Up to 2 hours after oocyte retrieval

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Study Director: Tahereh Madani, MD, Scientist; Principal Investigator: Ladan Mohmmadi yeganeh, MSc, Scientist

Publications and helpful links

General Publications

• Madani T, Mohammadi Yeganeh L, Khodabakhshi S, Akhoond MR, Hasani F. Efficacy of low dose hCG on oocyte maturity for ovarian stimulation in poor responder women undergoing intracytoplasmic sperm injection cycle: a randomized controlled trial. J Assist Reprod Genet. 2012 Nov;29(11):1213-20. doi: 10.1007/s10815-012-9854-3. Epub 2012 Sep 7.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 5, 2012
• First Submitted That Met QC Criteria: January 10, 2012
• First Posted (Estimate): January 13, 2012

Study Record Updates

• Last Update Posted (Estimate): January 13, 2012
• Last Update Submitted That Met QC Criteria: January 10, 2012
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: ICSI Ovarian stimulation; hCG low dose; Oocyte maturity; poor respond
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Royan-Emb-013