DRUG
Gonadotropin
withholding gonadotropin administration for at least 24 hours
Status
Completed
Phase
Phase 4
Enrollment
300
Locations
2
Results
Not posted
Publications
1
Study 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.
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.
Interventions
DRUG
withholding gonadotropin administration for at least 24 hours
DRUG
Cetrorelix acetate 0.25 mg
Timeline
First posted
Jun 24, 2019
Study start
Jul 1, 2019
Primary completion
Nov 10, 2019
Study completion
Nov 20, 2019
Results posted
Not reported
Registry updated
Nov 21, 2019
Outcomes
Number of high quality embryos
Time frame · Within 48 hours of fertilization
Number of high quality embryos
Not reported in the indexed record.
Eligibility
Inclusion Criteria: * infertile women * age 20-40 * at high risk for OHSS Exclusion Criteria: * refuse to participate
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Alazahr University
Cairo, Egypt
Assisted Reproduction Unit International Islamic Centre for Population Studies and Research, Al-Azhar University
Cairo, Egypt
Publications
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