Endometrial Receptivity After GnRH Agonist Triggering

IVI Madrid35 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

single shot of 6500 IU hCG s.c. at the time of triggering

triptorelinDRUG

single shot of 0.2mg triptorelin s.c. at the time of triggering

Triptorelin, estradiol valerate, micronized vaginal progesteroneDRUG

4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU

triptorelin, hCGDRUG

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

triptorelin, hCGDRUG

Multiple doses of 500 IU hCG (OPU, +4 and +7) and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU

triptorelin, recombinant LHDRUG

300 IU recombinant LH every 48h and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Instituto Valenciano de Infertilidad

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

endometrial receptivity gene expression profile

Time frame: participants will be followed for the duration of the cycle, an expected average of 4 weeks

Secondary Outcomes

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

Time frame: participants will be followed for the duration of the cycle, an expected average of 4 weeks

Data from ClinicalTrials.gov

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