Progesterone Levels During Ovulation and Luteal Phase in Spontaneous Natural Ovulatory Cycles vs Modified Natural Cycle. A Prospective Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ART Fertility Clinics LLC
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Difference in hormone levels
Overview
Brief Summary
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.
Detailed 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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy women below 40 years
- •Regular and Ovulatory cycles
Exclusion Criteria
- •Previous adnexal surgery
- •Endometriosis
- •Using hormonal contraception during the previous 2 months: OCP, progesterone IUD
Arms & Interventions
Modified Natural Cycle
- 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.
Intervention: human chorionic gonadotropin (Drug)
Outcomes
Primary Outcomes
Difference in hormone levels
Time Frame: 35 days
Small sample data will be analyzed with the use of non-parametric test like Wilcoxon test to a paired a test of difference in hormones levels of the patients represented in both cycles (PNC and MNC) (dependent samples). This test will be preferred due to non-independent interval or ratio data in addition not to meet the normality or homogeneity of variances assumptions as paired t-test. Hormonal pattern over the days (measured for some days during cycle 1 and cycle 2) will be analyzed using trend analysis (line fit).
Secondary Outcomes
- Number of visits in luteal phase(17 days)
- Luteal phase length(17 days)
Investigators
Laura Melado
Principal Investigator
ART Fertility Clinics LLC