Status:
TERMINATED
Low-dose HCG as an Adjunct to Ovarian Stimulation in Subfertile Women Undergoing ART
Lead Sponsor:
National and Kapodistrian University of Athens
Collaborating Sponsors:
University of Thessaly
Conditions:
HCG; IVF; Pregnancy Rates; ART; Chorionic Gonadotropin
Eligibility:
FEMALE
35-40 years
Phase:
PHASE3
Brief Summary
The objective of this prospective randomized clinical trial is to investigate whether the addition of low-dose hCG to a short GnRH-agonist protocol for IVF and ovarian stimulation with rFSH from the o...
Detailed Description
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, two parallel group of patients, Phase IIIb clinical study to test the efficacy and safety of adding low-dose hCGs in a...
Eligibility Criteria
Inclusion
- Age: between 35 and 40 years of age,
- Physiological menstrual cycles (24-35 day cycle),
- Normal endocrine function (normal PRL and TSH, FSH ≤ 15 IU / ml),
- Transvaginal ultrasound (TVS) without pathological findings,
- Free personal medical history,
- Indication for IVF / ICSI (NICE, 2016)
- 1st or 2nd IVF / ICSI cycle
Exclusion
- Endocrine or metabolic disorders, e.g. PCO (S)
- Pathology of the uterus and / or endometrium,
- Pelvic inflammatory disease (PID),
- Basal FSH levels\> 15 IU / ml,
- Surgery in the ovaries,
- Body Mass Index (BMI) ≥ 35 kg / m2,
- Age: \<35 years \&\> 41 years old
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03423537
Start Date
June 1 2018
End Date
April 30 2019
Last Update
March 30 2021
Active Locations (1)
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1
3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit
Athens, Chaidari, Greece, 12462