Effects of clomiphene citrate plus estradiol or progesterone on endometrial ultrastructure: An RCT.

Taheripanah R, Kabir-Salmani M, Favayedi M, Zamaniyan M, Malih N, Taheripanah A
International journal of reproductive biomedicine · 2020 · doi:10.18502/ijrm.v18i3.6718 · PMID:32309769 · PMC7142311
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This RCT found that adding estradiol or progesterone to clomiphene citrate did not significantly alter endometrial pinopods or serum estrogen levels, but serum progesterone was higher with clomiphene citrate alone.

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This randomized controlled trial evaluated the impact of adding estradiol valerate or progesterone to high-dose clomiphene citrate on endometrial ultrastructure in thirty women with unexplained infertility. Researchers assessed pinopod concentrations via scanning electron microscopy during the mid-luteal phase and found no statistically significant differences among the three treatment groups regarding these markers of implantation receptivity. Although serum progesterone levels were higher in the group receiving clomiphene alone, the addition of exogenous hormones did not significantly alter endometrial thickness, follicle count, or pinopod density compared to clomiphene monotherapy. The paper does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.

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Abstract

BackgroundPinopods concentrations in endometrial surface is a marker of implantation. Estradiol valerate (EV) was used to change the adverse effects of Clomiphene Citrate (CC) on the endometrium.ObjectiveThe goal was to assess whether there is a significant difference in the endometrial pinopods concentrations and other parameters after adding EV and progesterone to higher doses of CC.Materials and methodsIn this prospective randomized clinical trial, a total of 30 women who did not respond to 100 mg of CC from February 2016 to June 2016 were evaluated. They were divided into three groups: group I) received 150 mg of CC alone, group II) CC with EV, and group III) CC plus progesterone. On day 21 of the menstrual cycle, endometrial biopsy, a blood sampling, and a scanning by electron microscopy were performed.ResultsOn day 21 of the menstrual cycle, there was no significant difference in the pinopods concentrations (p = 0.641) and serum estrogen levels (p = 0.276) between groups. However, the Serum progesterone levels in group I was higher than the other two groups (p = 0.007) in the same day.ConclusionSince the addition of EV and progesterone to higher dosages of CC did not change the pinopods concentration and serum estrogen levels on day 21 of the menstrual cycle, and the serum progesterone levels was higher in CC alone group (i.e. group I) compared to other groups, it can be concluded that the anti-estrogenic effects of CC just appear on the endometrium and not on the plasma levels.
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There was no superiority of adding estradiol or progesterone supplementation to clomiphene citrate for enhancing pinopod concentration and endometrial thickness or serum estradiol levels in women who didn't response to clomiphene (Clomiphene failure). Yet, pinopod concentrations is slightly increased with adding estradiol which could be examined more again in future researches. Thus, it can be concluded that the anti-estrogenic effects of CC just appear on the endometrium not on the plasma levels.

Coi Statement

The authors declare that there are no potential conflicts of interest.

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