Ovarian Hyperstimulation Syndrome Clinical Trial
— ERAMADOfficial title:
Endometrial Receptivity After GnRH Agonist Triggering From Final Oocyte Maturation
Verified date | October 2016 |
Source | IVI Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
Conventional luteal phase support after human chorionic gonadotrophin (hCG) triggering in
women undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) provides
adequate pregnancy rates and live birth rates, but Ovarian hyperstimulation syndrome (OHSS)
still occurs in 1-3% of the patients. If gonadotropin-releasing hormone agonist (GnRHa) are
used instead of hCG, OHSS does not occur, but clinical results are somehow diminished.
By testing different luteal support protocols on women undergoing GnRHa triggering, the
investigators aim to find out which protocol resembles the most the gene expression profile
observed after hCG triggering and conventional luteal phase support, in order to choose it
as the most adequate in terms of endometrium receptivity and safety (OHSS incidence).
Status | Completed |
Enrollment | 35 |
Est. completion date | |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion criteria : - Healthy oocyte donor women - Aged 18-35 years - With a menstrual cycle length of 26-35 days - Normal ultrasound scan of uterus and ovaries - Normal basal hormones - No contraindication for controlled ovarian stimulation (COS) - Willing to participate in the study and providing written informed consent. Exclusion Criteria: - Subjects with current or previous history of an endocrine abnormality - Subjects with an abnormal outcome of blood biochemistry or hematology - Subjects with an abnormal cervical smear - Subjects with a chronic disease - Subjects with any relevant ovarian-, tubal- or uterine-pathology that could interfere with the COS treatment - Pregnancy - Subjects who had a previous history of ovarian hyperresponse or ovarian hyperstimulation syndrome (OHSS), polycystic ovary syndrome (PCOS) or a basal antral follicle count (AFC) of more than 20 on ultrasound (11 mm, both ovaries combined) . - Previous low ovarian response to FSH or hMG treatment (i.e. cycle cancelled due to insufficient ovarian response or less than 6 oocytes obtained). - A history of recurrent miscarriage, - Smoking more than 10 cigarettes per day. - Not willing to comply with study procedures |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Instituto Valenciano de Infertilidad | Madrid |
Lead Sponsor | Collaborator |
---|---|
IVI Madrid |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | endometrial receptivity gene expression profile | participants will be followed for the duration of the cycle, an expected average of 4 weeks | No | |
Secondary | Incidence of moderate/severe OHSS in all different treatment group | Mild OHSS Grade 1, abdominal distension and discomfort Grade 2, features of grade 1 plus nausea, vomiting and/or diarrhea; ovaries are enlarged from 5 to 12 cm Moderate OHSS Grade 3, features of mild OHSS plus ultrasonic evidence of ascites Severe OHSS Grade 4, features of moderate OHSS plus evidence of ascites and/or hydrothorax and breathing difficulties Grade 5, all of the above, plus change in the blood volume, increased blood viscosity due to hemoconcentration, coagulation abnormality, and diminished renal perfusion and function | participants will be followed for the duration of the cycle, an expected average of 4 weeks | Yes |
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