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The Effect of Luteal Blood Progesterone Levels on Ongoing Pregnancy Rates

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ClinicalTrials.gov Identifier: NCT04128436
Recruitment Status : Terminated (With the interim analysis, a marked decrease in ongoing pregnancy rate was noted in patients with a drop in serum progesterone level from OPU+3 day to OPU+5 day)
First Posted : October 16, 2019
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Anatolia IVF and Women's Health Center
Information provided by (Responsible Party):
Sezcan Mumusoglu, Hacettepe University

Brief Summary:

Progesterone (P4) is essential for the secretory development of endometrium and the maintenance of early pregnancy. In the luteal phase following controlled ovarian stimulation in in vitro fertilization (IVF) treatment, P4 profile is completely different from natural cycles (Fauser, 2002).

Since the optimal luteal P4 levels are not well known, in normal IVF treatment a standard regime of exogenous P4 is given without considering the ovarian response for stimulation and the steroid levels in luteal phase. In 2005 Humaidan et al, showed that following the fresh embryo transfer, low luteal P4 levels (39 nmol/l) has a negative impact on ongoing pregnancy rates (Humaidan, 2005). In the following randomized controlled trials (RCTs), the use of exogenous human chorionic gonadotropin (hCG) after gonadotropin releasing hormone (GnRH) agonist trigger as a luteal phase support (Humaidan, 2010, 2013), the mid luteal P4 levels increased to 77-409 nmol/l and birth rates per transfer raised to %24.

In the light of these, it is essential that the progesterone levels in luteal phase is above the certain threshold for induction of the normal secretory development of endometrium following the IVF treatment and for the maintenance of pregnancy.

The implantation window is defined as that period when the uterus is receptive for implantation of the free-lying blastocyst. For maximal effectiveness of assisted reproductive technologies in women, it is important to know the optimal time for embryo transfer which implies a need to predict the period of uterine receptivity. Blood progesterone levels can be an indirect indication for implantation window and the embryo transfer timing.

The aim of this study is to investigate the effect of early and mid luteal progesterone levels on ongoing pregnancy rates and to determine the optimal luteal P4 levels in IVF cycles following the fresh blastocyst transfer in order to improve the reproductive outcomes.


Condition or disease Intervention/treatment Phase
Luteal Phase Progesterone Levels Other: Taking blood samples for analyzing progesterone levels Not Applicable

Detailed Description:
During Covid-19 pandemic we decided to make an interim analysis in March 2020.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Early and Mid Luteal Blood Progesterone Levels on Ongoing Pregnancy Rates in IVF Cycles With Fresh Blastocyst Transfer
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Progesterone levels
Patients will be divided into groups according to quartiles (25/50/75) of progesterone levels. Optimal range of progesterone levels for ongoing pregnancy rate will be calculated.
Other: Taking blood samples for analyzing progesterone levels
As part of standard in vitro fertilization treatment, Crinone gel will be used starting the next morning following the oocyte pick-up (OPU) as a luteal phase support. On the trigger day, on the day OPU+2/3 (early luteal phase) and on the embryo transfer day (OPU+5, mid luteal phase) blood samples will be taken from patients for evaluating the progesterone levels. Blood samples will be collected at the 6th hour following the morning dose of vaginal progesterone gel. No other intervention will be done to the patients.




Primary Outcome Measures :
  1. Ongoing pregnancy rates [ Time Frame: 12 months ]
    Clinically proven pregnancy more than 12 weeks of gestation


Secondary Outcome Measures :
  1. Early luteal phase blood progesterone levels [ Time Frame: 12 months ]
    Concentration of blood progesterone on the day of OPU+2/3

  2. Mid luteal phase blood progesterone levels [ Time Frame: 12 months ]
    Concentration of blood progesterone on the day of OPU+5/ embryo transfer day



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cycles induced with GnRH agonist or GnRH antagonist protocol
  • BMI<35 kg/m
  • Retrieval of 3 or more metaphase II oocytes, irrespective of ovarian reserve testing

Exclusion Criteria:

  • Cycles triggered with GnRH agonist or dual trigger
  • Circulating progesterone > 1.5ng/mL on the day of trigger
  • Cleavage stage embryo transfer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128436


Locations
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Denmark
Aarhus University
Aarhus, Denmark
Turkey
Hacettepe University School of Medicine, Department of Ob/Gyn
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Anatolia IVF and Women's Health Center
Investigators
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Principal Investigator: Hakan Yaralı, Professor Hacettepe University
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Responsible Party: Sezcan Mumusoglu, Assistant Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT04128436    
Other Study ID Numbers: HU01
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sezcan Mumusoglu, Hacettepe University:
luteal phase
progesterone
in vitro fertilization
Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs