Endometrial Receptivity After GnRH Agonist Triggering

NCT01500863 | Completed Phase 4

• 1 other identifier: MAD-AB-ERA-2011
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

endometrial receptivity; gene arrays; agonist triggering; Endometrial gene expression; OHSS

Outcome Measures

Primary Outcomes (1)

• endometrial receptivity gene expression profile

  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

  participants will be followed for the duration of the cycle, an expected average of 4 weeks

Study Arms (6)

hCG

ACTIVE COMPARATOR

Drug: hCG

Triptorelin 0.2mg s.c.

EXPERIMENTAL

Drug: triptorelin

0.2mg triptorelin plus estradiol/progesterone

EXPERIMENTAL

Drug: Triptorelin, estradiol valerate, micronized vaginal progesterone

0.2mg tripoterlin plus single bolus hCG 1500 IU

EXPERIMENTAL

Drug: triptorelin, hCG

0.2mg tripoterlin plus multiple boluses hCG 500 IU

EXPERIMENTAL

Drug: triptorelin, hCG

0.2mg tripoterlin plus multiple doses recLH

EXPERIMENTAL

Drug: triptorelin, recombinant LH

Interventions

hCG DRUG

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

hCG

triptorelin DRUG

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

Triptorelin 0.2mg s.c.

Triptorelin, estradiol valerate, micronized vaginal progesterone DRUG

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

0.2mg triptorelin plus estradiol/progesterone

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

0.2mg tripoterlin plus single bolus hCG 1500 IU

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

0.2mg tripoterlin plus multiple doses recLH

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IVI Madrid: lead

Study Sites (1)

Instituto Valenciano de Infertilidad

Madrid, Madrid, 28035, Spain

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Triptorelin Pamoate; Estradiol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Alfonso Bermejo, MD

  IVI Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 29, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)