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Endometrial Receptivity After GnRH Agonist Triggering (ERAMAD)

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
hCG
triptorelin
Triptorelin, estradiol valerate, micronized vaginal progesterone
triptorelin, hCG
triptorelin, hCG
triptorelin, recombinant LH
Sponsored by
IVI Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Hyperstimulation Syndrome focused on measuring endometrial receptivity, gene arrays, agonist triggering, Endometrial gene expression, OHSS

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Valenciano de Infertilidad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

hCG

Triptorelin 0.2mg s.c.

0.2mg triptorelin plus estradiol/progesterone

0.2mg tripoterlin plus single bolus hCG 1500 IU

0.2mg tripoterlin plus multiple boluses hCG 500 IU

0.2mg tripoterlin plus multiple doses recLH

Arm Description

Outcomes

Primary Outcome Measures

endometrial receptivity gene expression profile

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2011
Last Updated
October 25, 2016
Sponsor
IVI Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT01500863
Brief Title
Endometrial Receptivity After GnRH Agonist Triggering
Acronym
ERAMAD
Official Title
Endometrial Receptivity After GnRH Agonist Triggering From Final Oocyte Maturation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVI Madrid

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
endometrial receptivity, gene arrays, agonist triggering, Endometrial gene expression, OHSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hCG
Arm Type
Active Comparator
Arm Title
Triptorelin 0.2mg s.c.
Arm Type
Experimental
Arm Title
0.2mg triptorelin plus estradiol/progesterone
Arm Type
Experimental
Arm Title
0.2mg tripoterlin plus single bolus hCG 1500 IU
Arm Type
Experimental
Arm Title
0.2mg tripoterlin plus multiple boluses hCG 500 IU
Arm Type
Experimental
Arm Title
0.2mg tripoterlin plus multiple doses recLH
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
hCG
Intervention Description
single shot of 6500 IU hCG s.c. at the time of triggering
Intervention Type
Drug
Intervention Name(s)
triptorelin
Intervention Description
single shot of 0.2mg triptorelin s.c. at the time of triggering
Intervention Type
Drug
Intervention Name(s)
Triptorelin, estradiol valerate, micronized vaginal progesterone
Intervention Description
4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
Intervention Type
Drug
Intervention Name(s)
triptorelin, hCG
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
triptorelin, hCG
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
triptorelin, recombinant LH
Intervention Description
300 IU recombinant LH every 48h and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
Primary Outcome Measure Information:
Title
endometrial receptivity gene expression profile
Time Frame
participants will be followed for the duration of the cycle, an expected average of 4 weeks
Secondary Outcome Measure Information:
Title
Incidence of moderate/severe OHSS in all different treatment group
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfonso Bermejo, MD
Organizational Affiliation
IVI Madrid
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Valenciano de Infertilidad
City
Madrid
ZIP/Postal Code
28035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Endometrial Receptivity After GnRH Agonist Triggering

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