Ovarian Hyperstimulation Syndrome
Conditions
Keywords
endometrial receptivity, gene arrays, agonist triggering, Endometrial gene expression, OHSS
Brief summary
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).
Interventions
DRUGhCG
single shot of 6500 IU hCG s.c. at the time of triggering
DRUGtriptorelin
single shot of 0.2mg triptorelin s.c. at the time of triggering
DRUGTriptorelin, estradiol valerate, micronized vaginal progesterone
4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
DRUGtriptorelin, hCG
single shot of 1500 IU hCG s.c. the day of OPU plus 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
DRUGtriptorelin, recombinant LH
300 IU recombinant LH every 48h and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
Sponsors
IVI Madrid
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| endometrial receptivity gene expression profile | participants will be followed for the duration of the cycle, an expected average of 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of moderate/severe OHSS in all different treatment group | participants will be followed for the duration of the cycle, an expected average of 4 weeks | 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 |
Countries
Spain
Outcome results
None listed