Infertility Female
Conditions
Keywords
Metformin, fecundability, uterine doppler
Brief summary
The basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus. Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to determine if Metformin helps to increase fecundability by affecting the uterus in women undergoing ART. As a surrogate marker- flows in the uterus will be tested during the treatment.
Detailed description
Obesity has been long implicated in reduced reproductive potential and it has been shown to impair conception and implantation. However, the basis for this adverse effect is still obscure and there is a controversy whether the key organ influenced by it are the ovaries or the uterus. It is well established that insulin resistance is one of the main mechanisms of obesity's negative influences on the reproductive organs in females. Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to determine if Metformin ,an oral antidiabetic and insulin sensitizer, helps to increase fecundability by affecting the uterus in women undergoing frozen-thawed embryo transfer compared to the control group. As a surrogate marker- flows in the uterus will be tested during the treatment.
Interventions
DRUGMetformin
Supplementation of the study group with Metformin till the day of pregnancy confirmation
Sponsors
The Baruch Padeh Medical Center, Poriya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age: from 18-40 years old. * BMI \> 30 * Infertile women undergoing frozen-thawed embryo transfer in an ART setting * Women with at least one Top graded embryo * Normal uterine Doppler indices at time of recruitment.
Exclusion criteria
* Diabetes mellitus - uncontrolled. * Hyperprolactinemia- uncontrolled. * Hypothyroidism- uncontrolled. * women who are already treated with Metformin * women with endometrial factor as the cause for infertility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pregnancy rate | until the blood test for pregnancy, about 4-6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The changes in Doppler blood flow indices in both uterine arteries | until the blood test for pregnancy, about 4-6 weeks |
| endometrial thickness change measured by millimeters | until the blood test for pregnancy, about 4-6 weeks |
| Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows | until the blood test for pregnancy, about 4-6 weeks |
Contacts
Primary Contactnora gorhad shabso, doctor
Outcome results
None listed