Human Chorionic Gonadotrophin in an Antagonist Protocol

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: Low dose HCG; Drug: Placebo

• Registration Number: NCT01833858
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

* 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.

Study Timeline

• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-17
• Study Start: 2013-08
• Primary Completion: 2014-10
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-01
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

1. Abnormal uterine cavity.
2. Basal (day 2 or 3) serum FSH levels ≥13 IU.
3. 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).
4. Untreated endocrinologic disease.
5. Azoospermia. all patients should be managed in Cairo,Egypt

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose HCG with rFSH	Low dose HCG	Low dose hCG (200 IU per day) will be given daily with rFSH 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
Placebo +rFSH	Placebo	Patients received rFSH injections with a placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.

Primary Outcome Measures

Name	Time	Method
Number of oocytes	9 months
Pregnancy rate	11months

Secondary Outcome Measures

Name	Time	Method
Cost of antagonist treatment	9 months
The percentage of the perifollicular vascularity using power doppler	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
Spiral artery Doppler indices	9 months	Spiral artery Doppler indices are taken as a marker of subendometrial vascularity.The lowest resistance will be the better vascularity

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt