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Human Chorionic Gonadotrophin in an Antagonist Protocol (HCG)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Low dose HCG
Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo +rFSH

Low dose HCG with rFSH

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of oocytes
Pregnancy rate

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2013
Last Updated
February 1, 2015
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT01833858
Brief Title
Human Chorionic Gonadotrophin in an Antagonist Protocol
Acronym
HCG
Official Title
The Role of Low Dose HCG in Improving the Quality of Antagonist Protocol in Patient Undergoing ICSI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo +rFSH
Arm Type
Placebo Comparator
Arm Description
Patients received rFSH injections with a placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.
Arm Title
Low dose HCG with rFSH
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Low dose HCG
Other Intervention Name(s)
Human chorionic gonadotrophin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline 0.9%
Intervention Description
Patients received rFSH injections with Placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.
Primary Outcome Measure Information:
Title
Number of oocytes
Time Frame
9 months
Title
Pregnancy rate
Time Frame
11months
Secondary Outcome Measure Information:
Title
Cost of antagonist treatment
Time Frame
9 months
Title
Spiral artery Doppler indices
Description
Spiral artery Doppler indices are taken as a marker of subendometrial vascularity.The lowest resistance will be the better vascularity
Time Frame
9 months
Title
The percentage of the perifollicular vascularity using power doppler
Description
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
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Serum level of inhibin A
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Human Chorionic Gonadotrophin in an Antagonist Protocol

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