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Evaluation of progesterone levels at oocyte retrieval and impact on pregnancy outcomes: a retrospective cohort study.

Evaluation of progesterone levels at oocyte retrieval and impact on pregnancy outcomes in women undergoing in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI): a retrospective cohort study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000824167
Enrollment
800
Registered
2019-06-07
Start date
2019-06-30
Completion date
2019-07-31
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Elevated progesterone on the day of hCG administration has been associated with significantly lower pregnancy rates when a fresh embryo transfer occurs. Although evidence is available to support this notion, numerous contradictory studies also exist . Presently, many clinics practice minimal stimulation and/or “minimal intervention” cycles, where patients are managed externally, and therefore patient’s progesterone levels at the time of hCG are not monitored. In 2014 Nayak et al demonstrated that elevated progesterone on the day of oocyte retrieval is associated with significantly lower implantaton and ongoing pregnancy rates. Implantation and pregnancy rates were significantly higher when the progesterone level was less than 12 ng/mL on the day of oocyte retrieval. Furthermore, miscarriage rates were higher when the P level was greater than or equal to 12 ng/mL, although this did not reach statistical significance. Premature progesterone elevation is believed to negatively impact endometrial receptivity however, premature progesterone rise has also been shown to have no effect on oocyte/embryo quality. Peripheral progesterone in the late follicular phase is likely to influence endometrial maturation. Endometrial samples exposed to low and high concentrations progesterone on the day of HCG administration had significantly different gene expression. These observations could explain the impairment of endometrial receptivity in the presence of elevated progesterone. Some reports discuss measures to prevent a premature progesterone rise, however once the progesterone rise has occurred then the optimal solution is to vitrify all embryos and transfer in a natural cycle. This method is supported by the fact that embryos obtained from cycles with an elevated progesterone and transferred into endometrium unaffected by elevated progesterone do not result in impaired pregnancy rates in either frozen-thawed or donor/recipients. Therefore, by evaluating progesterone levels at a time more proximal to embryo transfer, when patients must be in attendance with fertility staff, premature progesterone elevation could be identified so patient treatment could be modified to improve the chances of a successful pregnancy. Primary Objective: To determine the impact of serum progesterone concentration on the day of OPU on the probability of ongoing pregnancy in women undergoing IVF/ICSI. Secondary Objectives: To determine a progesterone cut-off value at oocyte retrieval that has the best capacity to discriminate between cycles that do and those that do not result in an ongoing pregnancy.

Interventions

Blood samples are routinely tested for hormonal changes during controlled ovarian stimulation for IVF/ICSI cycles. Progesterone levels at the time of oocyte retrieval, 36-38 hours after trigger, were assessed routinely. IVF/ICSI cycle outcomes were recorded and serum progesterone concentration used to determine the probability of ongoing pregnancy in women undergoing IVF/ICSI cycles. Observation duration is from oocyte retrieval to second trimester of pregnancy.

Sponsors

Fertility SA
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to 53 Years
Healthy volunteers
No

Inclusion criteria

Females aged 18 years or older Undergoing in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle using fresh or frozen ejaculated sperm from a male partner or sperm donor. Have serum progesterone recorded at the time of oocyte retrieval from the Fertility SA pathology laboratory.

Exclusion criteria

Oocyte Donors Women undergoing ovarian preservation for fertility preservation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026