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NCT Number: NCT01833858

Human Chorionic Gonadotrophin in an Antagonist Protocol

A novel gonadotropin protocol for ovarian stimulation adds low-dose hCG (50- 200 IU) as a source of LH (luteinizing hormone) in the late follicular phase .

This regimen reduces the number of small pre-ovulatory follicles which could reduce the risk of OHSS(ovarian hyper stimulation syndrome). Adequate ovarian hormonal levels , oocyte maturation, avoidance of a premature LH surge, and increased pregnancy rate are the other benefits of this regimen.

HCG might also affect endometrial function, stimulate endometrial growth and maturation and enhance the endometrial angiogenesis. These effects could extend the angiogenesis. These results could lengthen the implantation Window.

Inhibin A is a heterodimer protein and does not begin to increase until just after the increase in oestradiol in the late follicular phase, suggesting secretion by the dominant follicle. Inhibin A secretion is regulated by LH and is associated with paracrine/autocrine action on oocyte maturation. Moreover, it is related to follicular development and size, serving as a marker of follicular maturation after IVF cycles .However, the role of hCG supplementation during COH (controlled ovarian hyperstimulation)is still a matter of debate and more studies is needed. Thus, the objective of this trial was to investigate whether LH activity in the form of low dose hCG in GnRH (Gonadotropin releasing hormone)antagonist cycles would improve the quality of oocytes, level of inhibin A and endometrial vascularity.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cairo University

Cairo, Cairo Governorate, Egypt

About this study

  • 60 women, where 30 of them will receive low dose HCG with rFSH (group 1), while the other 30 women will receive rFSH (Recombinant Follicle stimulating Hormone) with a placebo (group 2) both using the antagonist protocol as a method of induction in ICSI.
  • Women in both groups will be treated with a GnRH antagonist protocol with cetrotide(cetrorelix)
  • In Group 1, low dose hCG (200 IU per day) with rFSH will be given daily when at least six follicles of 12 mm will be observed and E2 levels are higher than 600 ng/l, until the day of the hCG trigger administration.
  • Group 2 patients received rFSH injections with a placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.

In both groups Oocytes will be retrieved 36 h after the hCG trigger shot. All mature eggs retrieved will be fertilized with intracytoplasmic sperm injection (ICSI). Fertilization will be checked at 18 hours post insemination. Embryo quality will be assessed and embryo transfer will occur at day 3.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for ICSI treatment.
  • The presence of one or two functional ovaries.
  • Good responders to ovarian stimulation.
  • The presence of normal uterine cavity
  • Basal (day 2 or 3) serum FSH (follicle stimulating Hormone) levels ≤13 IU
  • No untreated endocrinologic disease

Exclusion criteria

  • Abnormal uterine cavity.
  • Basal (day 2 or 3) serum FSH levels ≥13 IU.
  • Poor responders to ovarian stimulation according to the existence of at least two of the following criteria:Advanced maternal age (above 40 years), antral follicles count <5, prior history of poor response to controlled ovarian hyperstimulation (peak E2 <500 pg/ml and/or ≤3 oocytes retrieved).
  • Untreated endocrinologic disease.
  • Azoospermia. all patients should be managed in Cairo,Egypt

Treatment and study plan

Low dose HCG

Drug

Low dose hCG (200 IU per day) will be given daily when at least six follicles of 12 mm will be observed and E2 (Estradiol) levels are higher than 600 ng/l, until the day of the HCG trigger administration.

Other names: Human chorionic gonadotrophin

Placebo

Drug

Patients received rFSH injections with Placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.

Other names: saline 0.9%

Primary outcomes

  1. Number of oocytes

    Time frame: 9 months

  2. Pregnancy rate

    Time frame: 11months

Secondary outcomes

  1. Cost of antagonist treatment

    Time frame: 9 months

  2. Spiral artery Doppler indices

    Time frame: 9 months

    Spiral artery Doppler indices are taken as a marker of subendometrial vascularity.The lowest resistance will be the better vascularity

  3. The percentage of the perifollicular vascularity using power doppler

    Time frame: 9 months

    The percentage of the perifollicular vascularity (<25%,25-50%,%0%-75%,>75%) as a marker of the quality of the oocytes.The more vascularity the better quality

Other outcomes

  1. Serum level of inhibin A

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Role of Low Dose HCG in Improving the Quality of Antagonist Protocol in Patient Undergoing ICSI

Acronym: HCG

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 17, 2013
Registry last updated
Feb 3, 2015

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.

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