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Completed

NCT Number: NCT01500863

Endometrial Receptivity After GnRH Agonist Triggering

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).

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Key information

Conditions

Ovarian Hyperstimulation Syndrome Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Valenciano de Infertilidad

Madrid, 28035, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCG

Drug

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

Triptorelin

Drug

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

Triptorelin, estradiol valerate, micronized vaginal progesterone

Drug

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

triptorelin, hCG

Drug

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, recombinant LH

Drug

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 outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

IVI Madrid

Other

Registry information

Official study title

Endometrial Receptivity After GnRH Agonist Triggering From Final Oocyte Maturation

Acronym: ERAMAD

Important dates

Study start
2011
Primary completion
2012
First posted
Dec 29, 2011
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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