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Luteal Phase Progesterone LevelsNCT04128436

The Effect of Luteal Blood Progesterone Levels on Ongoing Pregnancy Rates

A study testing Taking blood samples for analyzing progesterone levels in people with Luteal Phase Progesterone Levels, run by Hacettepe University at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages Up to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Luteal Phase Progesterone Levels
What is being tested?
Taking blood samples for analyzing progesterone levels
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
3 sitesin 3 countries
Study dates
1 Jan 2019to 11 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 40 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Brazil1 site
  • Androfert

    Campinas, São Paulo, 13075-460

Other trials in Brazil

Denmark1 site
  • Aarhus University

    Aarhus

Other trials in Denmark

Turkey (Türkiye)1 site
  • Hacettepe University School of Medicine, Department of Ob/Gyn

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Early and Mid Luteal Blood Progesterone Levels on Ongoing Pregnancy Rates in IVF Cycles With Fresh Blastocyst Transfer

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.

Read more

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.

In a recent study by Vuong et al., marked inter-personal variation in early luteal circulating P4 levels have been reported following the same hCG trigger dose; since a freeze-all policy was adopted in that study, the inter-personal variation during the early luteal phase was entirely caused by differences in endogenous P4 production from the CL (Vuong, et al., 2020). In this study, almost one in five patients had already experienced a peak P4 concentration on OPU+2 day to OPU+3 day, and only one in seven had maximal concentrations on OPU+6 day, showing that a total of 85% of women experienced their highest P4 concentration before the period in which the peak was expected to be reached during a natural menstrual cycle (Andersen, et al., 2020). It is noteworthy that more than 40% of patients had a >50% decrease in P4 concentration between OPU+4 day and OPU+6 day; although exogenous P4 supplementation in women undergoing IVF will ameliorate this drop-in serum P4 to some extent, these findings clearly highlight the requirement for studies examining how the probability of achieving pregnancy in fresh cycles is affected by the timing and magnitude of the reduction in P4 concentrations (Vuong, et al., 2020). Variations in endogenous production might, in theory, originate from differences in "quality" of the CL as seen during the natural cycle (Hull, et al., 1982) and/or differences in serum concentrations of hCG during the early luteal phase used for triggering (Vuong, et al., 2020b).

The aim of this study is two fold; i) to investigate the effect of early and mid luteal P4 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, ii) to investigate the impact of serial P4 levels on OPU+3 and OPU+5 and delta P4 (ΔP4; as calculated by subtracting the P4 level on OPU+3 from the P4 level on OPU+5) on ongoing pregnancy rates.

Read the detailed description

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

Since the shut down of the IVF clinics due to Covid-19 pandemic was over, we restarted our routine IVF practice and hence restarted recruitment of patients for this study.

Being tested
Taking blood samples for analyzing progesterone levels
Keywords
luteal phase, progesterone, in vitro fertilization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Taking blood samples for analyzing progesterone levelsOther

    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.

Study groups in NCT04128436
Study groupRoleWhat they receive
Progesterone levelsOtherPatients 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.
Receives: Other: Taking blood samples for analyzing progesterone levels

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ongoing pregnancy rates

    Clinically proven pregnancy more than 12 weeks of gestation

    Measured: 27 months

Secondary outcomes (3)
  1. Early luteal phase blood progesterone levels

    Concentration of blood progesterone on the day of OPU+2/3

    Measured: 24 months

  2. Mid luteal phase blood progesterone levels

    Concentration of blood progesterone on the day of OPU+5/ embryo transfer day

    Measured: 24 months

  3. Delta P4

    ΔP4; as calculated by subtracting the P4 level on OPU+3 from the P4 level on OPU+5.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2019
  2. Study start1 Jan 2019
  3. Primary completion11 Aug 2022
  4. Study completion11 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04128436
Sponsor's protocol ID
HU01
Status last verified
Aug 2022
First submitted
17 Sep 2019
Last updated
15 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Uyanik E, Mumusoglu S, Polat M, Yarali Ozbek I, Esteves SC, Humaidan P, Yarali H. A drop in serum progesterone from oocyte pick-up +3 days to +5 days in fresh blastocyst transfer, using hCG-trigger and standard luteal support, is associated with lower ongoing pregnancy rates. Hum Reprod. 2023 Feb 1;38(2):225-236. doi: 10.1093/humrep/deac255.

    PubMed 36478179

Questions about this trial

What is this clinical trial studying?

A study testing Taking blood samples for analyzing progesterone levels in people with Luteal Phase Progesterone Levels, run by Hacettepe University at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Brazil, Denmark, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ongoing pregnancy rates (time frame: 27 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04128436, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.

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