Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 71 of 414 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

Human Chorionic Gonadotrophin in an Antagonist Protocol (HCG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01833858
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Eman Elkattan, 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.


Condition or disease Intervention/treatment Phase
Infertility Drug: Low dose HCG Drug: Placebo Phase 2 Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Low Dose HCG in Improving the Quality of Antagonist Protocol in Patient Undergoing ICSI
Study Start Date : August 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo +rFSH
Patients received rFSH injections with a placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.
Drug: Placebo
Patients received rFSH injections with Placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.
Other Name: saline 0.9%

Active Comparator: Low dose HCG with rFSH
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
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.
Other Name: Human chorionic gonadotrophin




Primary Outcome Measures :
  1. Number of oocytes [ Time Frame: 9 months ]
  2. Pregnancy rate [ Time Frame: 11months ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Serum level of inhibin A [ Time Frame: 9 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833858


Locations
Layout table for location information
Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University

Layout table for additonal information
Responsible Party: Eman Elkattan, Dr., Cairo University
ClinicalTrials.gov Identifier: NCT01833858     History of Changes
Other Study ID Numbers: Protocol100
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs