Progesterone in Natural Cycles (PiNC)
Research type
Research Study
Full title
A Randomised Controlled trial investigating the effects of Progesterone for luteal phase support in Natural Cycles for unexplained infertility
IRAS ID
268496
Contact name
Claudia Raperport
Contact email
Sponsor organisation
Homerton University Hospital NHS Trust
Eudract number
2019-003468-27
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Unexplained infertility is diagnosed in up to 40% of couples referred to fertility units. This study is designed to assess whether treatment with progesterone supplements can improve pregnancy and live birth rates in natural cycles in couples diagnosed with unexplained infertility. Progesterone is widely used in all IVF cycles to support the lining of the womb after an embryo is transferred inside. There is a theory and some scientific evidence suggesting that women with unexplained infertility may be lacking in progesterone and there has never been a trial that has tested this.
We will perform a randomised controlled trial - one group will be given progesterone after they ovulate in their natural cycle and the other group will be given no treatment. We will compare pregnancy and live birth rates between the groups. Progesterone is widely used in IVF and also through pregnancy for various clinical indications so is known to be safe both pre-pregnancy and during pregnancy.The only study published that used progesterone in natural cycles did so as a control group comparing other groups with various medications used to stimulate ovulation. In this study, 24% of the women given progesterone alone had a live birth from up to 3 cycles of treatment. This compares with the results of established fertility treatments such as intrauterine insemination.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0532
Date of REC Opinion
29 Nov 2019
REC opinion
Further Information Favourable Opinion