Endometrial Receptivity After GnRH Agonist Triggering

Phase 4

Completed

• Conditions: Ovarian Hyperstimulation Syndrome
• Interventions: Drug: triptorelin, hCG; Drug: triptorelin, recombinant LH; Drug: Triptorelin, estradiol valerate, micronized vaginal progesterone; Drug: hCG; Drug: triptorelin

• Registration Number: NCT01500863
• Lead Sponsor: IVI Madrid

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-29
• Primary Completion: 2012-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
0.2mg tripoterlin plus multiple boluses hCG 500 IU	triptorelin, hCG	-
0.2mg tripoterlin plus single bolus hCG 1500 IU	triptorelin, hCG	-
0.2mg tripoterlin plus multiple doses recLH	triptorelin, recombinant LH	-
0.2mg triptorelin plus estradiol/progesterone	Triptorelin, estradiol valerate, micronized vaginal progesterone	-
hCG	hCG	-
Triptorelin 0.2mg s.c.	triptorelin	-

Primary Outcome Measures

Name	Time	Method
endometrial receptivity gene expression profile	participants will be followed for the duration of the cycle, an expected average of 4 weeks

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Instituto Valenciano de Infertilidad; 🇪🇸 Madrid, Spain