Addition of low doses of hCG in the rFSH stimulation of infertile women of older age who are undergoing IVF

Phase 1

• Conditions: Infertility; MedDRA version: 20.0Level: PTClassification code 10021928Term: Infertility femaleSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2016-005208-24-GR
• Lead Sponsor: Prof. Harry Siristatidis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-05
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1.Age: between 35 and 40 years,
2.Normal menstrual cycle (cycle duration: 24-35 days),
3.Normal endocrine function (normal values of PRL and TSH, FSH = 15 IU/ml),
4.Transvaginal ultrasound without abnormal findings,
5.Medical history devoid of any finding,
6.Indication for IVF/ICSI (NICE, 2016)
7.1st or 2nd IVF/ICSI cycle

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.?ndocrine or metabolic diseases, e.g. PCO (S)
2.Presence of any uterine or endometrium pathology,
3.Pelvic inflammatory disease (PID),
4.Basic FSH levels > 15 IU / ml,
5.Previous ovaries surgical intervention,
6.BMI = 35 kg/m2,
7.Age: < 35 & > 40 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified