The study will performed in healthy volunteers in order to get more insight in the mechanisms behind the insufficient luteal phase in patients treated with ovarian hyperstimulation for IVF.
Conditions
Interventions
E2 group: 8 Fem 7 patches (Estradiol 0.1 mg/cm2 Merck BV, Amsterdam, the Netherlands) applied on the buttocks on the day of the observed LH surge combined with 4 puffs (600ìg) Aerdiol® (Estrogen 150 ì
LH+5
morning 100 mg and evening 150 mg
LH+6: morning 300 mg and evening 300 mg.
E+P group: combination of above-mentioned regimens.
Non-treatment group
no medication.
Sponsors
N. Beckers, fertiliteitsarts, Room Hs 423, dr. Molewaterplein 40, 3015 GD Rotterdam. Tel: 010-4635738
Partially sponsored by Pantharhei
Eligibility
Inclusion criteria
Inclusion criteria: 1. Regular menstrual cycle (25-34 days); 2. normal body weight (BMI 18-28); 3. normal reproductive age (20-37 yrs); 4. normal early follicular phase FSH levels.
Exclusion criteria
Exclusion criteria: 1. Known or suspected pregnancy; 2. the use of oral contraceptives (i.e. Provera®, Mirena®, Nuva ring® ect.) in the last three months; 3. smoking habit; 4. subjects suffering from epilepsy; 5. diabetes mellitus; 6. gastrointestinal, hepatic, renal, and/or pulmonary diseases; 7. abnormal history; 8. use of other investigational drugs within 3 months and/or use of hormonal preparations-other then dose used for COH-within 1 month prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of the luteal phase. Every subject will undergo an end of trial visit. In this visit the subjects will hand over a paper on wich she will write down the onset of the menstuation. These data will be put into a excel database. | — |
Secondary
| Measure | Time frame |
|---|---|
| Endocrine profiles. Blood will be sampled every other day in the luteal phase from the day of the positive LH test until day LH+14. | — |
Contacts
Public ContactJ.T. Dissel, van
Leids Universitair Medisch Centrum Postbus 9600
Outcome results
None listed