Short summary

The key limiting step in IVF/ICSI treatment is successful implantation, which is dependent on high embryo quality and a functional luteal phase enabling the endometrium to reach the stage of receptivity. This study will determine whether mid-luteal progesterone as a predictor of sufficient luteal phase is correlated to implantation rate and on-going pregnancy rate and will define an optimal range for mid-luteal progesterone after IVF/ICSI in securing early pregnancy. Preimplantation Factor (PIF) is an embryo-specific peptide secreted only by viable embryos as early as the 2-cell stage. The second part of the study will explore the correlation between PIF and embryo development, implantation and on-going pregnancy rate in order to assess PIF as a possible tool in the selection of the most viable embryo for transfer.

Description of the cohort

Patients are enrolled from fertility centres in Skive, Odense, Horsens and Herlev. All women undergoing ART treatment in either GnRH-antagonist protocol or long GnRH-agonist protocol are offered participation.

Patients will receive standard treatments regarding stimulation, ovulation triggering, oocyte retrieval, embryo transfer (ET) and ultrasound examination according to the usual procedure of the participating clinics. Laboratory technics are conducted as normally. Luteal phase support is supplied as daily vaginal progesterone (Lutinus 100 mg x 3) from the day of ET continuing to the day of pregnancy testing. The only deviation from standard treatment at the clinics will be a total of 5-7 additional study blood tests during the IVF/ICSI cycle.

Exclusion criteria: prior participation in the study.

Data and biological material

Serum & embryo culture media.

Collaborating researchers and departments

The Fertility Clinic, Skive Regional Hospital

• Peter Humaidan, DMSc
• Lise Thomsen, MD
• Laboratory Director Karin Erb
• Laboratory Director Betina Boel Povlsen

The Society for the Investigation of Early Pregnancy, BioIncept LLC

• Eytan Barnea, MD

FACOG, The Fertility Clinic, Herlev Hospital

• Leif Bungum, MD, PhD

The Fertility Clinic, Horsens Regional Hospital

• Michael Aasted, MD

Department for Clinical Biochemistry and Pharmacology, Odense University Hospital

• Anette Thyrsted

Department of Biochemistry, Viborg Regional Hospital, Denmark

• Erland Erlandsen MSc
• Mette østergaard, MSc