Infertility, Female Clinical Trial
Official title:
Double Ovarian Stimulation in Cases of Preimplantation Genetic Testing: Comparison of Embryo Quantity and Embryonic Quality Using MitoScore
Verified date | December 2020 |
Source | IVI Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Since preimplantation genetic testing (PGT) is being more frequently requested from patients as women pursue infertility treatments at an advanced age with a poorer prognosis, sometimes physicians are compelled to perform several stimulation cycles to obtain more eggs and, consequently, a greater number of biopsied embryos. Hence, the idea of carrying out this study arises as an attempt to optimize each menstrual cycle to the maximum. It is believed that the double stimulation (DuoStim) protocol could be an alternative for this group of patients, allowing to obtain a larger number of oocytes in a shorter period, thus, increasing the number of biopsied embryos and possibly decreasing the interval to achieve a successful pregnancy. The investigators aim to evaluate the potential usefulness of the DuoStim protocol for patients desiring to obtain oocytes as soon as possible. Using PGT, the investigators will compare the rate of euploid embryos per cycle in patients undergoing DuoStim protocol versus patients undergoing two conventional controlled ovarian hyperstimulation in consecutive cycles. Patients will include women with advanced age and poor response. This is a unicentric, prospective, randomized, non-blind, parallel-group controlled phase IV clinical study. The investigators hypothesize that the rate of euploid embryos per cycle is similar in the DuoStim group compared to the group undergoing two conventional controlled ovarian hyperstimulation in consecutive cycles. Furthermore the investigators will evaluate if there are differences regarding the number of total oocytes obtained, the number of mature oocytes, the number of biopsied blastocysts and the MitoScore index of the available euploid embryos.
Status | Completed |
Enrollment | 136 |
Est. completion date | June 1, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 42 Years |
Eligibility | Inclusion Criteria: - Signed informed consent; - 35-42 years of age; - Patients from the IVI Madrid undergoing controlled ovarian hyperstimulation cycle including PGT analysis for infertility treatment; - BMI 18-30 kg/m2; - Suspicion of suboptimal or poor response: AMH < 1.5 ng/mL; AFC < 8; FSH > 10; Poor response in a previous cycle (defined as < 6 oocytes). Exclusion Criteria: - Simultaneous participation in another clinical trial or in any other study that could result in a confounding factor. |
Country | Name | City | State |
---|---|---|---|
Spain | IVI Madrid | Madrid |
Lead Sponsor | Collaborator |
---|---|
IVI Madrid |
Spain,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of euploid embryos per cycle | Rate of chromosomally normal embryos per cycle in the DuoStim group compared to the group undergoing two controlled ovarian hyperstimulation in consecutives cycles. | up to 9 months | |
Secondary | Number of oocytes obtained | Total number of oocytes obtained in both arms after ovarian puncture | up to 9 months | |
Secondary | Number of fertilized oocytes | Number of fertilized oocytes in both arms after FIV/ICSI procedure | up to 9 months | |
Secondary | Number of biopsied blastocysts | Number of biopsied blastocysts in both arms | up to 9 months | |
Secondary | MitoScore index of the euploid embryos | Analysis of the MitoScore index of the euploid embryos obtained in both arms | up to 9 months | |
Secondary | Implantation rate | Implantation rate of euploid embryos in both arms after single or double embryo transfer | up to 9 months | |
Secondary | Pregnancy rate | Pregnancy rate of euploid embryos in both arms after single or double embryo transfer | up to 9 months | |
Secondary | Abortion rate | Abortion rate presented by each arm after single or double embryo transfer | up to 9 months | |
Secondary | Time until embryo transfer | Period elapsed from the beginning of the ovarian stimulation until the embryo transfer | up to 9 months |
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