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The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | Luteal Phase support |
|
| control | No Intervention | No luteal Phase support |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| crinone (progesterone 8%, vaginal application) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate per IUI cycle | by ultrasound at ± 5 to 6 weeks after IUI |
| Measure | Description | Time Frame |
|---|---|---|
| live birth rate per IUI cycle | 40 weeks after IUI |
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Inclusion Criteria:
Patients with an indication for IUI:
Women:
Men: Total motile count ≥ 5 Million/ml after capacitation
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27565253 | Derived | Peeraer K, D'Hooghe T, Laurent P, Pelckmans S, Delvigne A, Laenen A, Welkenhuysen M, Wyns C, De Neubourg D. Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in intrauterine insemination cycles stimulated with gonadotropins: a randomized multicenter study. Fertil Steril. 2016 Nov;106(6):1490-1495. doi: 10.1016/j.fertnstert.2016.07.1096. Epub 2016 Aug 23. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C400424 | Crinone |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |