Impact of the clomiphene citrate intake on blood test and endometrium of women undergoing an in vitro fertilization treatment.

Conditions: MedDRA version: 14.1Level: LLTClassification code 10016398Term: Female infertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
Female infertility

Registration Number: EUCTR2011-002173-33-ES

Lead Sponsor: Fundació Privada EUGI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

- Oocyte donors
- Age between 18 and 35 years.
- BMI between 18 and 29 kg/m2
- Presence of both ovaries
- Caucasian phenotype
- Basal level of E2 < 80 pg/ml.
- Basal level P4 < 1.6 ng/ml
- FSH levels <12 IU/l at initiation of stimulation
- Not taking contraceptive pill
- Standard ovarian stimulation treatment and dose
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Polycystic ovarian syndrome
- Previous participation in the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of the 5-day CC administration during luteal phase on serum LH levels in oocyte donors.;Secondary Objective: To evaluate the impact of the CC administration on the development of the endometrium.;Primary end point(s): - Serum LH levels measured in the luteal phase;Timepoint(s) of evaluation of this end point: - 1st: Basal levels. (FSH, E2, and P4 required for inclusion).<br>- 2nd: On the ovulation triggering day.<br>- 3rd: On day 1 after OPU.<br>- 4th: On day 5 after OPU.<br>- 5th: On day 7 after OPU.<br>- 6th: On day 10 after OPU.<br>- 7th: On the first day of next period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Endometrial development on day 5 after Oocyte Pick-Up (OPU) studied by histological dating criteria of Noyes;Timepoint(s) of evaluation of this end point: - day 5 after OP