Infertility Clinical Trial
Official title:
The Ongoing Pregnancy Rate for Vitrification of Day-4 Morula and Day-5 Blastocyst
Verified date | June 2022 |
Source | Egyptian Foundation of Reproductive Endocrinology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparing the vitrification at Day-4 (morula stage) with the blastocyst stage vitrification outcomes with the transfer of all day 5 after warming seems need evaluation. To the best of our knowledge, there has been no random-controlled trial conducted such comparison. Altogether, this trial is to evaluate the morula stage vitrification to blastocyst vitrification on the ongoing pregnancy rate after ICSI.
Status | Terminated |
Enrollment | 53 |
Est. completion date | June 1, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Women age of = 18 to = 40 2. BMI of = 31 3. Normal responder (= 12 antral follicle count (AFC) during basal ultrasound examination) or hyper responder 4. The freeze-all groups including PCOS, OHSS, or high Progesterone at trigger day 5. Women who have = 1 year of primary or secondary infertility 6. Tubal factor (unilateral, bilateral obstruction or salpingectomy) 7. Fresh semen ejaculates but not frozen or surgically retrieved sperm 8. Male factor: oligoasthenozoospermia but not globozoospermia or pinhead sperm 9. Women who are undergoing their first or second ICSI attempts with a previously successful attempt 10. Women who undergo only freeze-all embryo 11. Freeze-all for poor endometrium at the fresh cycle 12. Freeze-all due to abnormal endometrial findings such as polyp or myoma with a decision for freeze all for surgical correction. 13. Women who have normal endometrial thickness (= 8) and echo-pattern at the time of progesterone start in the proposed vitrified warmed cycle Exclusion Criteria: 1. Women who have uncorrectable uterine pathology or abnormality including submucous myoma 2. Women or their husbands who have abnormal karyotyping 3. Women with a history of recurrent abortions or repeated implantation failures 4. Women who have uncontrolled diabetes 5. Women with diagnosed or undiagnosed liver or renal disease 6. Women who had a history of malignancy or borderline pathology 7. Women who will not meet the inclusion criteria 8. Women who will refuse to participate in the study 9. Women with endometriosis 10. Patient undergoing PGS or PGD 11. Surgically retrieved, frozen-thawed and pinpoint sperm or globozoospermia 12. Adenomyosis 13. Severe medical condition |
Country | Name | City | State |
---|---|---|---|
Egypt | Agial | Alexandria | |
Egypt | Al Hayat ICSI Centre of Alexandria | Alexandria | |
Egypt | AlMadina IVF and ICSI Centre | Alexandria | |
Egypt | Rahem Fertility Centre of Zagazig | Zagazig |
Lead Sponsor | Collaborator |
---|---|
Egyptian Foundation of Reproductive Endocrinology | Agial IVF/ICSI Unit of Alexandria, Egypt, Al Hayat ICSI Centre of Alexandria, Egypt, Al Madina Fertility centre of Alexandria, Egypt, Rahem Fertility Center of Zagazig, Egypt |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The ongoing pregnancy rate | Continued pregnancy at > gestational week 12 or more per initiated cycle | 12 weeks | |
Secondary | Biochemical pregnancy rate | positive b-hCG at = 14 days following embryo transfer per initiated cycle | 14 days | |
Secondary | Implantation rate | Sacs with a heartbeat on ultrasound per embryo transferred | 12 weeks | |
Secondary | Cumulative implantation rate | Sacs with a heartbeat on ultrasound per embryo transferred within one year from randomization | One year | |
Secondary | Clinical pregnancy rate | Sacs with a positive heartbeat on ultrasound at = 7 weeks of gestation per initiated cycle | 7 weeks | |
Secondary | Cumulative clinical pregnancy rate | Sacs with a positive heartbeat on ultrasound at = 7 weeks of gestation per initiated cycle within one year from randomization | One year | |
Secondary | Cumulative ongoing pregnancy rate | continued pregnancy after gestational week 12 per initiated cycle within one year from randomization | One year | |
Secondary | Twin pregnancy rate | = two foetuses with a heartbeat per initiated cycle | One year | |
Secondary | Embryo survival rate after thawing | Blastocyst re-expansion for day 5 vitrified embryo after two hours and blastocyst formation on day 5 for embryo vitrified on day 4 | Five days of culture |
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