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Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS

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ClinicalTrials.gov Identifier: NCT03996434
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : November 21, 2019
Sponsor:
Collaborators:
Cairo University
Al-Azhar University
Beni-Suef University
Information provided by (Responsible Party):
ClinAmygate

Brief Summary:
The aim of this work is to study the value of GnRH antagonist subcutaneous administration as an alternative to coasting in prevention of severe OHSS and its impact on embryos quality & the outcome of ICSI.

Condition or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome Drug: Gonadotropin Drug: Antagonist Phase 4

Detailed Description:

Infertility affects up to one in seven couples all over the world. In vitro fertilization-embryo transfer (IVF-ET) and intracytoplasmic sperm injection (ICSI) are commonly used in the management of infertility attributable to tubal factor, significant endometriosis, male factor and also persistent unexplained infertility. Recruitment and development of multiple follicles in response to gonadotrophin stimulation are necessary for successful assisted reproduction. In young ovulating women undergoing IVF treatment, the standard stimulation protocol can result in either poor response or ovarian hyperstimulation syndrome (OHSS).

OHSS is a serious and potentially life-threatening iatrogenic complication of controlled ovarian hyperstimulation (COH) which may cause serious impact on patient's health. OHSS is the most feared complication of IVF-related ovarian stimulation, which in its severe form leads to hospitalization and in the worst case scenario fatal complications. As many as 33% of IVF cycles have been reported to be associated with mild forms of OHSS. The incidence of moderate OHSS is estimated to be between 3% and 6%, while the severe form may occur in 0.1-3% of all cycles. Among high risk women the incidence approaches 20%.

Development of multiple follicles forms the basis of OHSS. Exogenous human chorionic gonadotrophin (hCG) administration for the final maturation of oocytes or endogenous production of hCG after pregnancy is the second factor needed for the development of severe OHSS. Severe OHSS is characterized by massive ovarian enlargement, pleural effusion, ascites, oliguria, hemoconcentration, and thromboembolic phenomena. Coasting is described as a withholding therapy while continuing with releasing hormone agonist/antagonist administration, until safe levels of estradiol (E2) are attained. GnRH antagonists causes an immediate suppression of E2 levels and therefore could prevent OHSS in GnRH antagonist cycles. A comparison between coasting and GnRH antagonist administration in women at high risk of OHSS during ovarian stimulation for IVF with GnRH agonist long protocol, in the hope of preventing the drawbacks of prolonged coasting.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Coasting Versus Gonadotrophin-Releasing Hormone Antagonist Administration in Patients at High Risk of Ovarian Hyperstimulation Syndrome and Its Impact on the Embryos Quality and the Outcome of ICSI
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : November 10, 2019
Actual Study Completion Date : November 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Coasting group
Including 150 patients who will undergo withholding gonadotropin administration for at least 24 hours before triggering ovulation with hCG. GnRH agonist will be continued daily till the day of triggering. E2 will be measured daily until the concentration falls to ≤ 3000 pg/ml, then 5000 IU of hCG will be given.
Drug: Gonadotropin
withholding gonadotropin administration for at least 24 hours

Active Comparator: Antagonist group

Including 150 patients who will receive GnRH antagonist (subcutaneous injection Cetrorelix acetate 0.25 mg (Cetrotide, Serono, UK)) daily until the day of hCG administration.

GnRH agonist will be discontinued at the start of antagonist administration.

E2 will be measured daily until the concentration falls to ≤ 3000 pg/ml and TVS revealed that follicles diameter is ≥ 18 mm, then 5000 IU of hCG will be given.

Drug: Antagonist
Cetrorelix acetate 0.25 mg
Other Name: Cetrorelix acetate




Primary Outcome Measures :
  1. Number of high quality embryos [ Time Frame: Within 48 hours of fertilization ]
    Number of high quality embryos



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infertile women
  • age 20-40
  • at high risk for OHSS

Exclusion Criteria:

  • refuse to participate

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): NCT03996434


Locations
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Egypt
Alazahr University
Cairo, Egypt
Assisted Reproduction Unit International Islamic Centre for Population Studies and Research, Al-Azhar University
Cairo, Egypt
Sponsors and Collaborators
ClinAmygate
Cairo University
Al-Azhar University
Beni-Suef University
Investigators
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Principal Investigator: Eman Elgendy, MD International Islamic Centre for Population Studies and Research

Publications of Results:
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Responsible Party: ClinAmygate
ClinicalTrials.gov Identifier: NCT03996434    
Other Study ID Numbers: Clin-I-0201907
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Local regulations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Hyperstimulation Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Cetrorelix
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists