Infertility Clinical Trial
— DOS/DOROfficial title:
Delayed Start to Ovarian Stimulation Improves Oocyte Maturation and Quality: A Randomized Trial
Verified date | May 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In couples with infertility secondary to Diminished Ovarian Reserve, the investigators hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.
Status | Terminated |
Enrollment | 30 |
Est. completion date | September 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Antral Follicle Count (AFC) less than or equal to 4 as measured by transvaginal ultrasound (TVUS), or - Cancellation of a prior IVF cycle due to poor ovarian response. - Patients will receive an antagonist stimulation protocol for IVF, or IVF with Intracytoplasmic Sperm Injection (ICSI). Exclusion Criteria: - Severe male factor infertility requiring surgical intervention to obtain sperm - Major uterine abnormality, - Preimplantation genetic diagnostic (PGD) testing, - Planned cycles without embryo transfer (for example, freeze-all, donor, or surrogate cycles). |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Center for Reproductive Health | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Merck Sharp & Dohme Corp. |
United States,
Blockeel C, Riva A, De Vos M, Haentjens P, Devroey P. Administration of a gonadotropin-releasing hormone antagonist during the 3 days before the initiation of the in vitro fertilization/intracytoplasmic sperm injection treatment cycle: impact on ovarian stimulation. A pilot study. Fertil Steril. 2011 Apr;95(5):1714-9.e1-2. doi: 10.1016/j.fertnstert.2011.01.028. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fertilization Proportions | Developmental competence (fertilization of oocytes) through standard in vitro fertilization (estimated time frame to be between 8-24 hours following IVF). This percentage will be calculated as the number of fertilized eggs ( 2PN stage) per total number of eggs collected from the egg retrieval. | 8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilization | |
Primary | Number of Oocytes Retrieved | The egg retrieval procedure will be performed 36 hours after the ovulation trigger. The procedure is estimated to take up to 1 hour at study visit as part of routine care. The number of retrieved eggs will be counted | up to 1 hour after oocytes retrieved | |
Secondary | Embryo Quality | Embryo quality will be assessed by the embryologist on days 2 or 3 (Cleavage stage) following IVF using standard embryo grading criteria. Embryos grading is based on three criteria: the number of blastomere cells present in the embryo, the degree of observed cell fragmentation and the degree of observed symmetry of the cells. | One hour on day 2 or 3 (following IVF procedure) | |
Secondary | Pregnancy Rates | Beta HCG levels will be assessed at 2 weeks and 3 weeks after embryo transfer. A positive pregnancy is defined as two positive beta HCG levels (a value > 5 mIU/ml ) observed over the time frame. | 2 to 3 weeks following embryo transfer | |
Secondary | Stages of Oocyte Nuclear Maturation | Quality of oocytes will be assessed for developmental stages (Germinal Vesicles, Meiosis I, or Meiosis II) | average of 1 to 2 hours on the Day of Retrieval | |
Secondary | Number of Mature Follicles | Maturation of follicles will be assessed by measuring the size of follicles (mature > 13mm) prior to (or at the time of) oocytes retrieval. | up to 1 hour (during the Transvaginal Ultrasound before Retrieval of Oocytes) | |
Secondary | Oocyte Recovery Rate | The number of oocytes recovered at the time of oocyte retrieval following ovarian stimulation. | up to 1 hours after oocyte retrieval |
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