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Endometrial Receptivity After GnRH Agonist Triggering

NCT01500863 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-10-26

No results posted yet for this study

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).

Conditions

  • Ovarian Hyperstimulation Syndrome

Interventions

DRUG

hCG

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

DRUG

triptorelin

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

DRUG

Triptorelin, estradiol valerate, micronized vaginal progesterone

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

DRUG

triptorelin, 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

DRUG

triptorelin, hCG

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

DRUG

triptorelin, 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 & Collaborators

  • IVI Madrid

    lead OTHER

Principal Investigators

  • Alfonso Bermejo, MD · IVI Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500863 on ClinicalTrials.gov