Endometrial Receptivity After GnRH Agonist Triggering (ERAMAD)

October 25, 2016 updated by: IVI Madrid

Endometrial Receptivity After GnRH Agonist Triggering From Final Oocyte Maturation

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28035
        • Instituto Valenciano de Infertilidad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hCG
Drug: hCG
single shot of 6500 IU hCG s.c. at the time of triggering
Experimental: Triptorelin 0.2mg s.c.
Drug: triptorelin
single shot of 0.2mg triptorelin s.c. at the time of triggering
Experimental: 0.2mg triptorelin plus estradiol/progesterone
Drug: Triptorelin, estradiol valerate, micronized vaginal progesterone
4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
Experimental: 0.2mg tripoterlin plus single bolus hCG 1500 IU
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
Experimental: 0.2mg tripoterlin plus multiple boluses hCG 500 IU
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
Experimental: 0.2mg tripoterlin plus multiple doses recLH
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endometrial receptivity gene expression profile
Time Frame: participants will be followed for the duration of the cycle, an expected average of 4 weeks
participants will be followed for the duration of the cycle, an expected average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of moderate/severe OHSS in all different treatment group
Time Frame: 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
participants will be followed for the duration of the cycle, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Investigators

  • Study Director: Alfonso Bermejo, MD, IVI Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

December 28, 2011

First Posted (Estimate)

December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAD-AB-ERA-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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