Human fertility Pregnancy and Childbirth
Conditions
Interventions
The method of randomisation: the history number of the patients is used for the randomisation: odd number goes to group 1, even number to group 2.
Group 1: Sperm cryopreservation will
Sponsors
iGLS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Couples who are interested in ART with an egg donation program 2. The male patients have to present a normozoospermic spermiogram and an age less than 45 3. The female patients have not to present endometrial alterations and an age less to 48
Exclusion criteria
Exclusion criteria: 1. Couples who are interested in ART with own eggs 2. Male patients with not normozoospermic spermiogram and an age greater than 45 3. Female patients with endometrial alterations and more than 48 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy rates, measured using the hormone ß-HCG for the positive beta, echography for the presence of sac, cardiac activity, all measured at one time (10 days after embryo transfer for the beta, in the 4th or 5th week after embryo transfer and 7th-9th week after embryo transfer, respectively). The results of the birth are obtained 10 months after embryo transfer. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sperm quality parameters (sperm count, motility, morphology, vitality, apoptosis and DNA integrity measured by flow cytometry), measured on the day of egg retrieval (post cryopreservation) 2. Sperm competence in terms of fertilization rate and blastocyst formation rate. The fertilization rate is the number of zygotes with good fertilization vs number of eggs, recorded the day after egg retrieval (day 1 of development). The blastocyst formation rate is the number of blastocyst vs zygotes, recorded on day 5 and 6 of development. 3. Embryo quality measured using Gardner’s cataloging (Gardner DK, Schoolcraft WB, 2008) and the kinetics of the embryos measured using an incubator with time-lapse technology. The embryo quality is assessed on day 5 and 6 (once a day) and the time-lapse data are collected on day 5 of development (once a day) 4. Chromosome status evaluated by PGD-A (Preimplantation Genetic Diagnosis for aneuploidy) and the results are obtained 20 days after egg retrieval | — |
Countries
Spain
Outcome results
None listed