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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

Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date November 21, 2019
Actual Study Start Date  ICMJE July 1, 2019
Actual Primary Completion Date November 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2019)
Number of high quality embryos [ Time Frame: Within 48 hours of fertilization ]
Number of high quality embryos
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
High quality embryos [ Time Frame: Within 48 hours of fertilization ]
High quality embryos
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Ovarian Hyperstimulation Syndrome
Intervention  ICMJE
  • Drug: Gonadotropin
    withholding gonadotropin administration for at least 24 hours
  • Drug: Antagonist
    Cetrorelix acetate 0.25 mg
    Other Name: Cetrorelix acetate
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Gonadotropin
  • 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.

    Intervention: Drug: Antagonist
Publications * Aboulghar MA, Mansour RT, Amin YM, Al-Inany HG, Aboulghar MM, Serour GI. A prospective randomized study comparing coasting with GnRH antagonist administration in patients at risk for severe OHSS. Reprod Biomed Online. 2007 Sep;15(3):271-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 20, 2019
Actual Primary Completion Date November 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • refuse to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996434
Other Study ID Numbers  ICMJE Clin-I-0201907
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Local regulations
Responsible Party ClinAmygate
Study Sponsor  ICMJE ClinAmygate
Collaborators  ICMJE
  • Cairo University
  • Al-Azhar University
  • Beni-Suef University
Investigators  ICMJE
Principal Investigator: Eman Elgendy, MD International Islamic Centre for Population Studies and Research
PRS Account ClinAmygate
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP