None listed
Conditions
Brief summary
With advancements in cryopreservation techniques and widespread use of frozen embryo transfer (FET) in assisted reproductive technology, debate still exists around the optimal method for preparing the endometrium for embryo transfer. A protocol that achieves ovulation and gives a degree of flexibility to the timing of embryo transfer would be highly appealing to both patients and IVF clinics. The progesterone modified natural FET (P4mNFET) protocol has been proposed as one such method, whereby progesterone supplementation is commenced prior to ovulation, once certain ultrasound criteria are met. Given the relative paucity of data in the literature, this pilot study will recruit 20 women to undertake a P4mNFET in order to (a) confirm the presence/absence of a corpus luteum and (b) compare outcomes to a cohort undertaking a true natural FET.
Interventions
Progesterone 200mg vaginally twice daily, commencing on identification of a follicle with mean diameter of 14mm or more and endometrial thickness of 7mm or more, and continuing until 8 weeks of gestation.
Pessaries will be self-administered.
Adherence to the intervention will be monitored by tracking the return of the drug product.
Frozen embryo transfer is performed under transabdominal ultrasound guidance after 5 days of progesterone supplementation. This represents the same duration of proge
Progesterone 200mg vaginally twice daily, commencing on identification of a follicle with mean diameter of 14mm or more and endometrial thickness of 7mm or more, and continuing until 8 weeks of gestation. Pessaries will be self-administered. Adherence to the intervention will be monitored by tracking the return of the drug product. Frozen embryo transfer is performed under transabdominal ultrasound guidance after 5 days of progesterone supplementation. This represents the same duration of progesterone treatment as clinic's routine true natural frozen embryo transfer protocol.
Sponsors
The Royal Women's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Women who have regular menstrual cycles: 21-35 days. Patients undertaking natural thaw of single embryo transfer attending the Public Fertility Services. BMI 18-35. Between 18-40 years of age. No uterine pathology: congenital anomalies, endometrial polyps, intrauterine adhesions, adenomyosis, fibroids
Exclusion criteria
Anovulatory women Uterine pathology: congenital malformations, endometrial polyps, intrauterine adhesions, adenomyosis, fibroids Women with contraindications to exogenous progesterone supplementation (eg., liver disease, thromboembolic disease)
Outcome results
None listed