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.
ID
Bron
Verkorte titel
Aandoening
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.
Ondersteuning
Partially sponsored by Pantharhei
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL475 |
| NTR-old | NTR516 |
| Ander register | : VPG 03.01 |
| ISRCTN | Incomplete data for ISRCTN |