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Administration of a multicomponent dietary supplement (myo-inositol, vitamin D3, folic acid and melatonin) to women undergoing IVF procedures.
The aim of the study is to monitor the effects on the pregnancy, implantation and abortion rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator |
| |
| Study group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| control group | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implantation rate | number of gestational sacs observed at ecographic screening divided by the number of embryos transferred | Single time-point: at 6 weeks of pregnancy |
| oocyte and embryo quality | Classification of the morphological aspects under the optical microscope | Single time-point: respectively, 12 days and 15 days after the beginning of Controlled Ovarian Hyperstimulation |
| clinical pregnancy | Positive beta-hCG test after embryo transfer | Single time-point: at 14 days from embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Gemellarity | Multiple gestational sacs observed at ecographic screening | Single time-point: at 6 weeks of pregnancy |
| Abortion rate | Loss of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Alma Res | Roma | RM | 00198 | Italy |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| study group | Dietary Supplement |
|
|
| Single time-point: at 6 weeks of pregnancy |
| Number of FSH IU used for controlled ovarian hyperstimulation | Ovarian ultrasound investigation and serum estradiol level | Single time-point: about 10 days after the beginning of Controlled Ovarian Hyperstimulation |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D008722 | Methods |