Endometrial Receptivity After GnRH Agonist Triggering

Ovarian Hyperstimulation Syndrome Clinical Trial

— ERAMAD  

Official title:

Endometrial Receptivity After GnRH Agonist Triggering From Final Oocyte Maturation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500863
• Other study ID #: MAD-AB-ERA-2011
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2011
• Last updated: October 25, 2016
• Start date: November 2011

Study information

• Verified date: October 2016
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome

Intervention

Drug:
• hCG
single shot of 6500 IU hCG s.c. at the time of triggering
• triptorelin
single shot of 0.2mg triptorelin s.c. at the time of triggering
• Triptorelin, estradiol valerate, micronized vaginal progesterone
4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
• 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
• 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
• 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

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endometrial receptivity gene expression profile		participants will be followed for the duration of the cycle, an expected average of 4 weeks	No
Secondary	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	participants will be followed for the duration of the cycle, an expected average of 4 weeks	Yes