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This is a single center, 3 arms, prospective randomized controlled open study to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.
Patients will be randomized into 3 groups:
Study design:
single center, 3 arms, prospective randomized controlled open study
Objective:
to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.
Methods:
All patients in all study groups will undergo a single insemination procedure and then will be randomized into 3 groups:
Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test. If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luteal support with progesterone only | Experimental | Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. |
|
| Luteal support with estrogen + progesterone | Experimental | Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg]. |
|
| No luteal support | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luteal support with progesterone only | Drug | Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel).Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy | A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test | 4 weeks after insemintation |
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Inclusion Criteria:
Exclusion Criteria:
female partners with one or more of the following:
sever male factor < 5 million total motile sperm on the day of insemination.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Galia Oron | Contact | 972-3-9377492 | orong@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Galia Oron, Dr | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | 49202 | Israel |
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|
| Luteal support with estrogen + progesterone | Drug | Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group. |
|
| Insemination without luteal support | Procedure | Routine insemination procedure without luteal support |
|
| ID | Term |
|---|---|
| D004967 | Estrogens |
| D011374 | Progesterone |
| D007314 | Insemination |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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