Progesterone Levels During Ovulation and Luteal Phase

ART Fertility Clinics LLC

Status: Completed

Conditions: Infertility, Female

Treatments: Drug: human chorionic gonadotropin

Study type: Observational

Funder types: Other

Identifiers

NCT05076981

2107-ABU-009-LM

Details and patient eligibility

About

Natural cycles are evaluated during fertility treatments for different therapeutic options, like insemination (IUI), time intercourse (TI) or frozen-thawed embryo transfers (FET). Two possible protocols can be used for natural cycles, with or without hCG trigger. Usually, studies including natural cycles consider both options as equivalent, not considering the possible bias that the exogenous hCG (human chorionic gonadotrophin) might have. In this prospective study, Investigators aim to evaluate the differences in the hormonal profile during the ovulation when it occurs spontaneously vs triggered with a bolus of hCG.

Full description

For the pure natural cycle (PNC), ovulation will be detected by a combination of ultrasound monitoring the follicular growth and serial measurement of luteinizing hormone (LH), estradiol (E2) and progesterone (P4) levels, which is recognised to be the most accurate method of correctly identifying ovulation.

For the modified natural cycle (MNC), a bolus of rhCG 6500 IU subcutaneous (sc) will be administered when 1 dominant follicle reaches 17mm or above, after excluding previous LH surge. This is the first prospective study where the differences on the hormonal profile for ovulation will be studied.

HYPOTHESIS:

H0: The hormonal profile is not different between the PNC and the MNC H1: The hormonal profile is different between the PNC and MNC

Administration of hCG is a popular method for triggering ovulation since it may avoid the need to perform IUI or FET at weekends. However, it is an intervention compared with the detection of the spontaneous LH rise. Moreover, due to the presence of hCG receptors in the human endometrium, administration of hCG might interfere with endometrial receptivity. Previous publications evaluating pregnancy rates demonstrated that the use of hCG injection during the natural cycle reduces the pregnancy rates, in FET and IUI. It remains unclear what might be the mechanism to explain the lower pregnancy rates: a possible direct effect of hCG on the hCG receptors of the endometrium or a modification of the hormonal profile after the administration of the hCG, affecting the window of implantation (WOI).

Enrollment: 6 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy women below 40 years
• Regular and Ovulatory cycles

Exclusion criteria

• Previous adnexal surgery
• Endometriosis
• PCOs
• Using hormonal contraception during the previous 2 months: OCP, progesterone IUD

Trial design

6 participants in 2 patient groups

Pure Natural Cycle

Description:

* Transvaginal ultrasound (TVUS) on day 2/3 of cycle + hormones FSH, LH, E2, P4 (IVF1) * TVUS day 9-10 of cycle to identify dominant follicle. * Blood test for IVF1 every 24h until identification of the LH surge. * The LH surge will be diagnosed when the concentration rises by 180% above the latest serum value available in that patient and continued to rise thereafter (Fatemi et al, 2010). * Once the LH rise is detected, blood test for IVF1 to be performed after 2h, and then every 12h after LH rise for 2 days. * During luteal phase, IVF1 day 7 after LH rise and day 14 after LH rise.

Modified Natural Cycle

Description:

* Transvaginal ultrasound (TVUS) on day 2/3 of cycle + hormones FSH, LH, E2, P4 (IVF1) * TVUS day 9-10 of cycle to identify dominant follicle. * Once the dominant follicle reaches 17mm or above, a bolus of 6500 rhCG (Ovitrelle, Merck-Serono) will be administered subcutaneously. IVF1 to be performed just before the rhCG-administration. * IVF1 2h after rhCG. * IVF1 every 12h for 2 days after rhCG. * During luteal phase, IVF1 day 7 after rhCG and day 14 after rhCG.

Treatment:

Drug: human chorionic gonadotropin