N/A
N=204
Oocyte Cryopreservation Registry (HOPE Registry)
Oocyte Cryopreservation
Bottom Line
View on ClinicalTrials.gov: NCT00699400 ↗Enrolled (actual)
204
Serious AEs
—
Results posted
Jan 2014
Primary outcome: Primary: Thawing Cycle Level Live Birth Rate — 12.4; 15.0; 13.6 % of oocytes thawed per cycle
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- EMD Serono
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Thawing Cycle Level Live Birth Rate |
12.4; 15.0; 13.6 | — |
| SECONDARY Oocyte Level Live Birth Rate |
4.2; 7.4; 6.5 | — |
| SECONDARY Number of Live Babies |
17; 84; 101 | — |
| SECONDARY Number of Oocytes Frozen |
1144; 3721; 4865 | — |
| SECONDARY Number of Oocytes Thawed |
416; 1282; 1698 | — |
| SECONDARY Oocyte Survival Rate |
73.2; 83.3; 80.6 | — |
| SECONDARY Implantation Rate |
15.9; 41.7; 35.1 | — |
| SECONDARY Number of Clinical Pregnancies |
18; 73; 91 | — |
| SECONDARY Number of Miscarriages |
4; 10; 14 | — |
Summary
Phase IV, prospective multicenter, observational Registry will track cycle outcomes for subjects who are thawing frozen oocytes for subsequent use through in vitro fertilization (IVF) and embryo transfer (ET)
Eligibility Criteria
Inclusion Criteria
- Must be in an ART program
- Donor and recipients must be of reproductive age (18-50 years old, inclusive at the time of oocyte freezing and/or thawing) who intend to achieve a pregnancy by utilizing frozen thawed autologous or heterologous oocytes
- Female and partner (if applicable) must voluntarily provide written informed consent/HIPAA authorization prior to any Registry-related data collection
- Female and partner (if applicable) must be willing to provide a second written informed consent following each live birth prior to any Registry- related data collection on birth characteristics and twelve (12) month evaluation of offspring
- Children born from women who take part in this registry from birth to 12 months (+/- 1 month) of age
Exclusion Criteria
- Have clinically significant systemic disease
- Have abnormal, undiagnosed gynecological bleeding
- Have any contraindication to Controlled Ovarian Stimulation (COS) for ART and to gonadotropins to be used in ART
- Also, in a rare situation, are undergoing ET with mixed embryos generated from fresh oocytes produced in the current cycle as well as frozen embryos generated from nonfrozen oocytes obtained in a previous ART cycle
- Children born from women who do not take part in this Registry
- Any offspring of woman who are not Registry subjects cannot take part in this registry
Data sourced from ClinicalTrials.gov (NCT00699400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.