Human Chorionic Gonadotrophin in an Antagonist Protocol

Infertility Clinical Trial

— HCG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833858
• Other study ID #: Protocol100
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 4, 2013
• Last updated: February 1, 2015
• Start date: August 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Low dose HCG
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.
• Placebo
Patients received rFSH injections with Placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum level of inhibin A		9 months
Primary	Number of oocytes		9 months
Primary	Pregnancy rate		11months
Secondary	Cost of antagonist treatment		9 months
Secondary	Spiral artery Doppler indices	Spiral artery Doppler indices are taken as a marker of subendometrial vascularity.The lowest resistance will be the better vascularity	9 months
Secondary	The percentage of the perifollicular vascularity using power doppler	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	9 months