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Endometrial Receptivity After GnRH Agonist Triggering (ERAMAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IVI Madrid
ClinicalTrials.gov Identifier:
NCT01500863
First received: December 20, 2011
Last updated: October 25, 2016
Last verified: October 2016
  Purpose

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).


Condition Intervention Phase
Ovarian Hyperstimulation Syndrome
Drug: hCG
Drug: triptorelin
Drug: Triptorelin, estradiol valerate, micronized vaginal progesterone
Drug: triptorelin, hCG
Drug: triptorelin, recombinant LH
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Endometrial Receptivity After GnRH Agonist Triggering From Final Oocyte Maturation

Further study details as provided by IVI Madrid:

Primary Outcome Measures:
  • endometrial receptivity gene expression profile [ Time Frame: participants will be followed for the duration of the cycle, an expected average of 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 35
Study Start Date: November 2011
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: 0.2mg tripoterlin plus multiple boluses hCG 500 IU 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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500863

Locations
Spain
Instituto Valenciano de Infertilidad
Madrid, Spain, 28035
Sponsors and Collaborators
IVI Madrid
Investigators
Study Director: Alfonso Bermejo, MD IVI Madrid
  More Information

Responsible Party: IVI Madrid
ClinicalTrials.gov Identifier: NCT01500863     History of Changes
Other Study ID Numbers: MAD-AB-ERA-2011 
Study First Received: December 20, 2011
Last Updated: October 25, 2016
Health Authority: Spain: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by IVI Madrid:
endometrial receptivity
gene arrays
agonist triggering
Endometrial gene expression
OHSS

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Estradiol
Polyestradiol phosphate
Progesterone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Triptorelin Pamoate
Deslorelin
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins
Luteolytic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 05, 2016