- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01833858
Human Chorionic Gonadotrophin in an Antagonist Protocol (HCG)
The Role of Low Dose HCG in Improving the Quality of Antagonist Protocol in Patient Undergoing ICSI
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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.
|
Patients received rFSH injections with Placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.
Other Names:
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of oocytes
Time Frame: 9 months
|
9 months
|
Pregnancy rate
Time Frame: 11months
|
11months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost of antagonist treatment
Time Frame: 9 months
|
9 months
|
|
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
|
9 months
|
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
|
9 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum level of inhibin A
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
King's College LondonNot yet recruitingInfertility | Infertility, Female | Infertility Unexplained | Infertility of Tubal Origin
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Istanbul University - Cerrahpasa (IUC)RecruitingInfertility | Sexual Dysfunction | Infertility, Male | Nurse's Role | Sexuality | Infertility; FemaleTurkey
-
Jinling Hospital, ChinaRecruitingMale Infertility Due to HypospermatogenesisChina
-
Cairo UniversityCompleted
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States