Endometrial Receptivity After GnRH Agonist Triggering

NCT ID: NCT01500863

Last Updated: 2016-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

hCG

Group Type: ACTIVE_COMPARATOR

hCG

Intervention Type: DRUG

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

Triptorelin 0.2mg s.c.

Group Type: EXPERIMENTAL

triptorelin

Intervention Type: DRUG

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

0.2mg triptorelin plus estradiol/progesterone

Group Type: EXPERIMENTAL

Triptorelin, estradiol valerate, micronized vaginal progesterone

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

triptorelin, hCG

Intervention Type: 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 multiple boluses hCG 500 IU

Group Type: EXPERIMENTAL

triptorelin, hCG

Intervention Type: DRUG

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

0.2mg tripoterlin plus multiple doses recLH

Group Type: EXPERIMENTAL

triptorelin, recombinant LH

Intervention Type: 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

Interventions

hCG

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

Intervention Type: DRUG

triptorelin

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

Intervention Type: DRUG

Triptorelin, estradiol valerate, micronized vaginal progesterone

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IVI Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfonso Bermejo, MD

Role: STUDY_DIRECTOR

IVI Madrid

Locations

Instituto Valenciano de Infertilidad

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

MAD-AB-ERA-2011

Identifier Type: -

Identifier Source: org_study_id