Assisted reproduction and the early luteal phaseThe effect of ovulation induction on the endocrine profile

Phase 1

• Conditions: Infertility, particularly the luteal phase during IVF; MedDRA version: 17.1Level: LLTClassification code 10016398Term: Female infertilitySystem Organ Class: 100000004872; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2013-003304-39-DK
• Lead Sponsor: Fertilitycenter Odense

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-02
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 179

Inclusion Criteria

All participation patientes have to give a spoken and written informed concent.
1) Women 18-40 years of age, 2)BMI over 18 kg/m 2 or under 35 kg/m 2
3) Planed IVF or ICSI with GNRH protocol 4) Normale value of af FSH, LH, estradiol, TSH and prolaktin.

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 179
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

women under 18 or over 40 years old, BMI under 18 kg/m 2 or over 35 kg/m 2, Women in GnRH agonist protocol, Severe ilness of heart, lung or kidney, epilepsy, endocrine disorder, koagulation disorder, allergy towards 17- hydroxy progesteron, progesteron, benzylalkohol, ethyloleat, hydroxypropylbetadex or water. Patientes with HIV or hepatitis infection. Secondarily if transferation is canceled.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the endocrine hormone levels in the luteal phase during fertility treatment.;Secondary Objective: Not applicable;Primary end point(s): Hormones level of 17-a-hydroxy progesterone, Progesterone, Estradiol, HCG, Inhibin A and possibly PAPP A and PP14<br>;Timepoint(s) of evaluation of this end point: Date of pregnancy test, approximately 2 weekes

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Positive pregnancy test, clinical pregnancy and featus with heartbeat.;Timepoint(s) of evaluation of this end point: 7 weeks