No registrations found.
ID
Source
Brief title
Health condition
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.
Sponsors and support
Partially sponsored by Pantharhei
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
N/A
Study objective
The hypothesis will be tested that early luteal phase administration of high dosages of Estradiol and/or Progesterone in normo-ovulatory volunteers will reduce the luteal phase length.
Study design
N/A
Intervention
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 ìg/spray, Servier, Leiden, the Netherlands) every 3 hours on the day of LH. The patches were removed after the blood sampling on day LH+4.
P group: Prontogest i.m injections (Progesterone amp, 100 mg/ml, AMSA, Roma, Italia). Started on day LH+4: evening 25 mg; 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.
Postbus 9600
J.T. Dissel, van
Leids Universitair Medisch Centrum
Afdeling Infectieziekten, C5P
Leiden 2300 RC
The Netherlands
+31715262613
j.t.van_dissel@lumc.nl
Postbus 9600
J.T. Dissel, van
Leids Universitair Medisch Centrum
Afdeling Infectieziekten, C5P
Leiden 2300 RC
The Netherlands
+31715262613
j.t.van_dissel@lumc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL475 |
| NTR-old | NTR516 |
| Other | : VPG 03.01 |
| ISRCTN | Incomplete data for ISRCTN |