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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01500863
Other study ID # MAD-AB-ERA-2011
Secondary ID
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. completion date
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
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