Skip to main content
OpenTrials
Completed

NCT Number: NCT01509833

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

37 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • indication for ICSI treatment, second or third cycle
  • Age 37 to 43 years
  • Body mass index (BMI) ≤ 30 kg/m2
  • The presence of two functional ovaries and no previous ovarian surgery
  • The presence of normal uterine cavity and 2 normal tubes base on recent hysterosalpingographic or hysteroscopic evaluation
  • Basal (day 2 or 3) serum FSH levels ≤13 IU/L
  • Normal semen analysis
  • No history or signs of endometriosis
  • No untreated endocrinologic disease

Treatment and study plan

rFSH

Drug

Administration of rFSH for ovarian stimulation.

HCG

Drug

Administration of late follicular low dose hCG(100IU) for ovarian stimulation.

Primary outcomes

  1. Number of mature oocytes

    Time frame: Up to 2 hours after oocyte retrieval

    Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval

Secondary outcomes

  1. Number of retrieved oocytes

    Time frame: Up to 1 hour after oocyte retrieval

    Evaluation the number of retrieved oocytes Up to 1 hour after oocyte retrieval

  2. Number of generated embryos

    Time frame: Up to 48-72 hours after oocyte retrieval

    Evaluation the number of generated embryos up to 48-72 hours after oocyte retrieval.

  3. Quality of generated embryos

    Time frame: Up to 48-72 hours after oocyte retrieval

    Evaluation the Quality of generated embryos up to 48-72 hours after oocyte retrieval.

  4. Number of transferred embryos

    Time frame: on the time of embryo transfer

    Evaluation the number of transferred embryos on the time of embryo transfer.

  5. Quality of transferred embryos

    Time frame: on the time of embryo transfer

    Evaluation the quality of transferred embryos on the time of embryo transfer.

  6. implantation rate

    Time frame: 4 weeks after embryo transfer

    Evaluation the implantation rate 4 weeks after embryo transfer.

  7. chemical pregnancy rates

    Time frame: 2 weeks after embryo transfer

    Evaluation the chemical pregnancy rates 2 weeks after embryo transfer.

  8. clinical pregnancy rates

    Time frame: 4 weeks after embryo transfer

    Evaluation the clinical pregnancy rates 4 weeks after embryo transfer.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2012
Registry last updated
Jan 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.